Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Korea
www.kfda.go.kr
Food
Drug
Administration
Yun-Hong Noh
Regulatory Reform to Enhance the Public Assurance, 22 01 Industry Activity and the Nation's Status
CONTENTS
Introduction
22 22 25
1. Regulatory Reform Directions of 2010 2. Details of Regulatory Reform 3. Regulatory Reform Assessment
28 03 International Trade and Cooperation in Food and Drug 14 15 16 18 01 The Top 6 Priority Tasks 02 Missions 03 History 04 Vision / Mission / Aim
28 28 31 1. Outline 2. International Trade 3. International Cooperation
1. Establishment of Cooperative Network with Consumer Organizations 2. Civil Service KiFDA System 3. Telephone and Online Counseling
Chapter 03 Food
Preparing the Organic and Systematic Safety Management from Raw 105 03 Material to Consumption
105 110 113 114 116 1. Safety Management Activity for Food Distribution 2. Establishment of Safety Management System for Imported Food 3. Improvement of Safety Management for Alcohol 4. Establishment and Operation of Food Safety Information Center 5. Improvement of the Food Labeling System for Realization of Sovereignty of Customers
119 136
1. Safety Management of Health Functional Food 2. Improvement of Safety Management for Genetically Modified Food and Novel Food
Reorganizing Standards and Specification for Food, Food Additives, 142 05 Equipment, Container and Packaging
142 145 147 148 149 1. Management Food Standards and Specification 2. Systematical Management of Food Substance 3. Management of Food Additives Regulation 4. Management of Regulation and Specification for Utensils, Container and Packaging 5. Management of Standards and Specification for Disinfectant of Equipments
1. The Domestic-Global Trend of High Tech Biomedicine 2. Domestic and Foreign Trend of Vaccine Industry 3. Prospects of Biopharmaceutical Products
205
Fostering the Biopharmaceutical Products and Building the 206 03 Foundation of Support System
206 206 208 1. Outline 2. Innovation of the Customer-Focused Evaluation 3. Management of the Public-Private Communication Channel; Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO)
Reinforcement of Safety Management Infrastructure for Medicine 214 05 and Herbal Medicine
214 218 1. Building the Safety Management System for Korean Herbal Medicine 2. Approval and Evaluation of Herbal Medicines
Enhancement of Status as an International Institute for Test 288 02 Analysis and Research
288 288 289 289 290 1. Overview 2. Development of Document Management System for Quality Assurance of Test Analysis 3. Production and Provision of Reference Standard 4. Enhancement and Development of Test 5. Construction of an Advanced Core Laboratory
International and Scientific Approaches to Medical Device Standards 265 03 and Specification
265 265 266 1. Overview 2. Current Status in Medical Devices Standards and Specifications 3. Future Directions
Providing Scientific Basis for Advanced License Screen 291 03 System and Safety Management
291 296 299 299 301 303 1. Study on the Safety Management of Pharmaceuticals 2. Research on the Safety Management of Biological Drugs 3. Study on the Safety Management of Herbal Medicines 4. Study on the Safety Management for Cosmetics and Quasidrugs 5. Study on the Safety Management of Medical Devices 6. Customized Support from Initial R&D Design to Final Drug Approval
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Introduction
Missions
We will protect and improve the public health by securing the safety of food, pharmaceuticals, medical devices and etc. and promoting competitiveness of healthcare industries
Korea Food and Drug Administration (KFDA) (Headquarter)
Strategic organization based on development of safety control policies and control tower Performance of top 5 roles in reinforcing political and strategies Development of policies Establishment of standards Pre-market approval Post-market inspection Management of product quality system Evaluation department conducts establishment of standards, approval and review
4. Reform of the regulations on food and medicine promoting voluntariness and fairness
Leading zero-based reform for regulations to enhance industrial autonomy Reasonable revisions or adjustment of standards for punishment and penalty to reinforce autonomy and responsibility of industries
National Institute of Food and Drug Safety Evaluation (NiFDA ) A think-tank for scientific safety control
Research and development, risk assessment, test analysis, development of test methods and approval and evaluation methods, and etc. Establishment of the scientific and technical support system to conduct KFDA's policy and political affairs of the nation
Regional KFDA Reinforcement of abilities as a regional specialized institution and complete differentiation from local government
Conduct HACCP and GMP inspection and etc. Cooperation with local government for sanitary inspection and etc.
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History
August 2011
Headquarters, 1 Government, 5 Bureaus, 49 Sections, 1 Team, 1,460 Employees The National Tax Service transferred Liquor Safety Management responsibilities of to the KFDA. Adverse Effect inspection Team of the Nation Institute od Food and Drug Safety Evaluation was abolished and became Pharmaceutical Safety Information Team under Pharmaceutical Safety Bureau of the KFDA. Evaluation Science Division of the NIFDS changes their name to Pharmaceutical Standardization Research and Testing Division. The KFDA relocated to Osong Health Technology Administration Complex, Osong, ChungBuk during November. The KFDA Headquarters was previously comprised of 1 Officer, 5 Bureaus(5 Departments), 65 Divisions, but the composition was changed to 1 Officer, 5Bureaus(1 Officer and 4 Departments), 48 Divisions. Criminal Investigations Office, and Foreign Inspection Division were established National Institute of Toxicological Research was transformed into National Institute of Food and Drug Safety Evaluation(3 Departments, 18 Divisions > 3 Departments, 29 Divisions). I nnovation Planning Officer, and Laboratory Test Management Team were abolished, and creation and innovation Officer, and Laboratory Audit Team were newly formed instead. Headquarters were changed to bureaus, and the Team-based System became Division-based. The responsibility of treating and caring narcotic addicts was transferred to the ministry for Health, welfare and Family Affairs. pokesperson system was introduced for the advanced system for the press coverage, KFDA S also reinforced its staff and newly created 5 teams. Bureau for Risk Management, information Management Team, Customer Support Team, Novel Food Team, Clinical Management Team, Herbal Medicine Management Team, Cosmetics Evaluation Team, Biologics Management Team, Herbal Medicine Evaluation Team, Medical Devices Quality Management Team were founded. he organization of 2 Offices, 2 Bureaus, and 6 departments was restructured into 6 T Headquarters, and 4 Departments. Team-based system was introduced to all Divisions. and Bioproduct Technical Support Division.
2010
2009
2008
2007 2006
June
2005
The organization was restructured with the creation of Medical Devices Management Division, 2004
2003 2002
KFDA newly established Health Functional Food New Division, Health Functional Food Standardization Division, and Biologics Standardization Division along with the increase in staff. The National Center of Toxicological Research was reorganized to National institute of Toxicological Research Food and Drug Adminstration)
The Korea Food and Drug Safety Headquarter was raised to the status of adminstration(Korea February 1998
April
1996
Korea Food and drug Safety Headquarter and six Regional Offices were established. Four departments of the National Institute of Health were reorganized to six Safety Evaluation departments. The National Institute of public Health Safety Research was reorganized to National Center of Toxicological Research
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To secure the highest level of public health by ensuring the safety of food, drugs, medical devices and cosmetics Prevention, action, support for the enhancement and protection of national healthcare, and securing of food and drug safety
Abundant expert knowledge View for the future Passion for the best Cooperation by through communication
Purpose
We protect
Sufficient Protection Smart Support Speedy Response
through the prevention, response and support for food and pharmaceutical safety.
national health
Sufficient prevention through elimination of risk factors in advance and enhancement of vulnerability
Smart support and cooperation for the establishment of the best food and pharmaceutical safety basis
Speedy response and appropriate risk management to reduce and recover accidents regarding food and pharmaceutical safety
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Chapter 01
1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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Once the amendment of the policy is complete, it is expected to promote the development of ready-to-eat food items while opening up ~5,600 jobs in instant food manufacturing and processing industry.
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1) Outline
Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status
In 2010, the KFDA planned regulatory reform projects with the private sector, as a private-government sector joint project, with the aim to assure the public, invigorate the industries and enhance the Nation's status. New projects were discovered through open meetings (Open Maru), the public opinions and policy forums, whereby the public and the industries raised their opinions. Also, 102 existing policies were chosen as regulatory reform projects, discovered by basic reviews.
The KFDA also exempted the submission of GMP assessment data per item for pharmaceuticals of exporting purposes during their approval requests and allowed companies to follow the GMP regulation of the foreign country importing Korean products. As a result, about 30 Korean companies are exploring or in the progress of exporting their products to advanced countries like the U.S. and Europe. The combined export output is expected to be around 155,200 million won (raw materials: 25,000 million won, complete product: 130,200 million won).
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3) S upport for Prompt Commercialization (Approval and Evaluation) of Biopharmaceuticals such as Vaccines
There already existed a prompt approval system for preventive vaccine of infectious disease or pandemics. However, it required appropriate modifications to address the need raised by experiencing swine flu endemics. Biopharmaceuticals require advanced technology and a high-level of know-how for the establishment of production plants and commercialization (approval and evaluation). However, there are not enough experts and professional consulting organizations available to provide supports accordingly. Therefore, Article 36 of Regulation on Item Approval and Evaluation of Biopharmaceutical Products was segmented by epidemic phases, to specify data submission range, time and method, in an effort to systemize the standards of epidemic vaccines. The KFDA also functioned as the relevant companies partner or consultant to support efficient commercialization of biopharmaceuticals from initial development to approvals. Consequently, the scientific response system was prepared, and time wasted by companies was minimized through pre-consultation on new vaccine development or building/relocation of manufacturing plants.
As a result, the release period of newly developed medical devices were sped up to a maximum of 43 days, and cost of obtaining approvals was reduced.
Satisfaction research showed that 86.7% were satisfied with the amended regulation (October, 2010, conducted by the KFDA).
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1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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National standards were moved by specific refrigerant and freeze containers, keeping the highest (higher than 8) and lowest (lower than 2) temperature by automatic temperature recording devices. High risk pathogens were loaded after being packed into deep freezers and were tracked with GPS during its transportation.
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1. Outline
Transportable cages (sterilizing material) were used to move laboratory animals, while maintaining suitable temperatures and ventilating the vehicle. In case of frozen gametes, proper containers to maintain their frozen status were used. For items such as national standards and laboratory animals, the National Emergency Management, the National Police Agency and the Korea Highway Corporation gave assistance in safe relocation of precious cargoes. In November 2010, KTX Osong station and a new express bus route from Seoul to Osong opened to improve the residency condition. Also, shuttle buses were provided for commuters who have their residences around Osong. Finally, 91 official apartments were sold, and 21 were rented out to employees. Also, employees who purchased housings Chungbuk Province received tax exemptions.
The KFDA successfully completed its relocation project that began in November 2010 by March 2011, establishing a foot step to develop as an advanced bio industry cluster suitable for 21st century. The relocation project aimed to minimize the issues raised by the inability to work and secure facilities for convenient lifestyle through safe and efficient move of office and laboratory equipments.
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1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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2) FTA
Korea already agreed to the FTA with Chile, Singapore, EFTA, ASEAN, India, EU and Peru. Recently, Korea-India CEPA went through official negotiations (12 times), inter-
03
1. Outline
sessional negotiations (3 times) and vice-minister level talks (2 times) since 2006, and all of the issues reached the settlement on the 12th negotiation in September, 2008 and subsequently took an effect on January 1, 2010. EU is the second biggest trading partner for Korea after China. Korea-EU FTA is expected to be the catalyst for economic development, right after Korea-U.S. FTA, and it took an effect on July 1, 2011. Korea-Peru FTA is not expected to be highly effective for trade, but it took an effect on August, 2011 for bilateral resource cooperation and to provide an opportunity for Korean industry to enter Central and South American market. Out of all the FTA agreements, Korea-U.S. FTA in 2006 received the most concerns. Both Korea and the U.S. went through 8 negotiations after the first one in June 2006, and it reached the settlement on April 2, 2007. More negotiations were held until in February 10, 2011, where additional agreements were signed. The major content of the additional agreement that is closely related to the role of the KFDA is the extension of the transitional period from one and half year to three years, given for the mandatory implementation of the pharmaceutical approval and patent system. Korea-U.S. FTA ratified agreement is currently being reviewed by the National Assembly. Korea-U.S. FTA mainly covers the intellectual property rights of pharmaceutical
In the rapidly changing environment, food and drug safety management became one of most significant fields of government management that is directly related to the health of the nation. With the increase of import and export of food and medicine in the era of globalization, it is becoming essential that some degree of trade cooperation with international organizations and foreign governments must exist. Trade cooperation with international counterparts are being made in two principal types; WTO (World Trade Organization) as multinational cooperation and FTA (Free Trade Agreement) as bilateral cooperation.
2. International Trade
1) WTO
The KFDA directly and indirectly participates in the Agreement on the Application of Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) of the WTO, actively responding to pending issues related to Korean safety policy on food and drug, and negotiating with members if required to protect the health of the Korean public. The KFDA also notifies newly established or amended regulations and policy related to SPS and TBT to members through the WTO secretariat (34 cases in 2010). It is also providing responses to inquiries made by members while working as the inquiry point to analyze SPS/TBT notifications. These are subsequently delivered to the related organizations and private associations.
products, especially, in approval-patent scheme. If Korea permits the use of patent information by the generic medicine manufacturer, the KFDA is to notify the patent holder of such request if the patent period is still active. Also, the KFDA will prohibit sales of generics that did not gain the patent holders permission (while patent period is still active). The infringement of a patent is currently determined after the sales of generic medicine. However, once this scheme is implemented, the infringement is determined during the generic medicine approval procedure. When the Korea-U.S. FTA takes an effect, the Korean government will establish the method and procedure to maximize the balance of profit made between the patent holder and the generic company. Also, a cooperative foundation was prepared for cross recognition of Good Manufacturing Practice (GMP) and Good Laboratory Practice (Glop, and intergovernmental medicine - medical devices committee to discuss
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relevant issues and collaborative, as the result of the FTA. Korean government, in the short term, prepared the implementation method to minimize the possible damage on domestic companies. In the long run, the KFDA plans to promote the policy to enhance the international competitiveness of Korean pharmaceutical industries (Columbus project etc.). Currently, Korea is in the progress of negotiating FTA with 12 countries, including Australia and New Zealand, and in the progress of joint research on FTA with 23 countries, including China and Japan. Korea-China FTA is expected to create a relatively large ripple effect compered to current FTAs in progress. China has the largest amount of food and drug imports and exports as Koreas first trade partner and recently showed continuous economic growth. Korea opened the industry-government-academia for joint research with China in March 2007, and both trade ministers signed the MOU to close the joint research during May 2010. Also, both countries held the first pre-intergovernmental consultation in September 2010. As the Korea-China FTA negotiation approaches, the KFDA is discovering and analyzing the medical issues and preparing relevant strategies.
3. International Cooperation
Continuous exchange and cooperation with all the countries of the world and international organizations is particularly prominent in the fields of foods, drugs, cosmetics and medical devices. The KFDA is putting an effort on the protection and enhancement of the nations health by reinforcing the cooperative partnership with international organizations like the WTO and leading trade partners such as China, U.S. and EU. The KFDA is also promoting video-conferences with Health Sciences Authority (HSA) of Singapore, where both countries signed the MOU in June 2010, and promoted the establishment of conciliation with the countries in South Asia, such as Indonesia and Malaysia. Up until now, the KFDA signed the cooperation with State Food and Drug Administration (SFDA) of China for food, drug, cosmetic and medical equipment, General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of China on food safety cooperation, Department of Health of Vietnam and Chile, Singapore HSA, the WHO for International Program on Chemical Safety Cooperation Agreement, Western Pacific Regional Office (WPRO) of the WHO, and Food Standards Australia and New Zealand (FSANZ). The Commissioner of the KFDA visited AQSIQ and SFDA in China in May 2011. At the meeting with AQSIA, both organizations reached an agreement to share organic information based on Japanese Nuclear Plant Incident of Fukusima that threats the safety of food. In the meeting with SFDA, the delegations reached an agreement to improve of cooperation for biosimilars and cosmetics, as well as the expansion of cooperation for medical devices and health functional food, establishing the foundation for Korean companies to enter the Chinese market. For the current condition of cooperation by countries, a total of 66 cooperation agreement were signed by August 2011. Out of the total, 51 (77%) contracts were with domestic organization, and 15 (23%) with foreign organizations.
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1. R egulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. S uccessful Relocation of Osong Health Technology Administration Complex 3. I nternational Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
EU
51 (77%)
04
Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service
The KFDA has dispatched 2 food and drug safety officers to Beijing and Qingdao of China and 1 officer to Washington D.C of U.S., as an effort to resolve the problems of entering China and U.S. market of foods, drugs, cosmetics and medical devices through the site support. Also, 4 officers were dispatched to the WHO and the CODEX Alimentarius to improve cooperation and raise Koreas status in international communities in regards to food and drug safety. The KFDA is also actively conducting the international collaborations by attending international meetings and conducting on-site inspections of foreign manufacturers and companies. In 2010, there were a total of 327 overseas trips recorded, and 5% of these trips required pre-authorization. Table 1-3-2 Overseas Work Trip Status
Preliminary examination is unnecessary Year Inter -national meeting 33 (10%) Cooper -ation meeting 40 (12%) on-site inspec -tion 159 (49%) Preliminary examination is necessary Training 22 (7%) Total Inspection, reward field trip, system, visit, data encourage acquisition -ment 17 (5%) 0 (0%) 327
2010
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07. 3.30
09. 6. 1
Kim Jae Ok
701, Seoul YWCA hall, 1-1, Myeongdong1774-4050 ga, Joong-gu, Seoul 32737117 7749702~7 7524227~9 739-5530 22653627~8 325-3300
Lee Deok Seung Kang Gyo Ja Kim Cheon Joo Kim Jae Ok Lee Yoon Ja
5-393, Hyochang-dong, Yongsan-gu, Seoul 1-2, Myeongdong1-ga, Joong-gu, Seoul 6th floor, Sangdong-building, 1-2, Namchang-dong, Joong-gu, Seoul 603, Pearson-building, 89-27, Sinmoonro2-ga, Jongro-gu, Seoul 19-3, Choonmuro5-ga, Joong-gu, Seoul
579-0603
272-1, Hannam-dong, Yongsan-gu, Seoul 795-1042 1st floor, YMCA building, 117, Sogongdong, Joong-gu, Seoul 445-9, Hapjeong-dong, Mapo-gu, Seoul 754-7891 7017321~2
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2007 12 595
2008 13 835
2009 12 654
2010 13 727
directly provides the information requested through telephone inquiries. Lastly, it also established the honorary consultant system formed with retired officials by December, 2010 to provide expert advices. Table 1-4-4 Civil Services Statistics (2009 2010)
The new statistics list of 2011 2009 2010 National license 3,244 3,510 Standard and test method 8,599 6,648 Approval and registration 349,425 388,958 General civil affairs 16,763 23,097
(Unit: case)
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accident, such as the past melamine, talc and radiation incidents. It takes all the anger of the nation, delivers the apology of the KFDA and provides information of a response measure and future policy. The centers role will continue to grow as the bridge between the KFDA and nation. However, the satisfaction of connecting the KFDAs divisions with the public is all up to the operation of the consultation center. Figure 1-4-2 Homepage of General Consulation Center (http://call.kfda.go.kr)
2006
16,626 11,190
2007 115,506 46,349 31,502 20,006 17,649 18,859 12,887 2008 136,856 68,756 36,432 23,062 2009 165,751 82,644 44,222 28,916 8,606 9,969 25,473 16,779 28,659 18,228
*Others: inquiries for information of staff, department, phone number, location and how to use online service
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1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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The number of food collection and tests, rejection rates, food poisonings reports and patient numbers are provided through E-Index Korea. Figure 1-5-1 Policy Statistics Publication for 2010
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1. Outline
According to the increased importance of the policy and clinical statistics, the International Trade and Statistics Office was installed on April 30, 2009, to handle all of statistics of the administration. It is largely divided policy and clinical statistics. Policy statistics provide the scientific foundation for the establishment, enforcement and evaluation of safety policy by verification, quality test and statistical analysis of food, drug and medical devices. Clinical statistics support the expansion of information sharing, pre-consultation for approval requests and professional statistical techniques, in order to vitalize the industry. The International Trade and Statistic Office also amended the Regulation for Statistics Performance in the KFDA (established regulation of KFDA #166, February 1, 2010) for systemic statistical workflow. This amendment established the Principle for Statistical Data Providing and Method (Article 15 and 16), obligated the consultation with Officer of Planning and Coordination when the statistics data is needed for a project (Article 11), defined education planning, statistics quality test plans, methods and procedures according to the higher legislation (Article 6 and 7), and established and operated statistic databases and service systems (Article 17 and 18).
2. Policy Statistics
After implementation of Policy Management System based on Statistics (enforcement ordinance of statistical Act 33, Presidential decree 20826, June 20, 2008), statistics are being actively used to establish and evaluate policies. To provide statistical information of the KFDAs performance and affairs for food, drug, health functional food, biopharmaceuticals, cosmetics and medical devices, the Office annually publishes Food and Drug Statistics Report. In 2010, the 12th report, composed with 206 items, was published. Statistics Collection of Industry and Sourcebook of Major Statisctics were also published in the same year. Information on national statistics, such as food and food additives output, imported food condition, collection and test result, are provided through the Korean Statistical Information Service (KOSIS).
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Field
The name of new statistics The current status on test animal production-import-sale The amount of used animal for health care-medical affairs The amount of discarded test animal in test animal facility The amount of discarded test animal in test animal supporter The record on risk information collection The record on annual professional/general drug production The local degree of complete drug self support The local degree of raw material drug self support The current status on complete drug corporations divided by scale The current status on raw material drug corporations divided by scale The current status on corporation divided by employment scale The current status on drug export corporation divided by countries The current status on drug import corporation divided by countries The current status on manufacturing-export-import of antibiotic drugs The information on proper usage of drugs The current status of locally developed new drug and improved new drug The current status on annual DMF notification The current status on biological equality test approval The current status on suitability assessment of biological equality test organization The number of anticancer drug test plan approval The current status on pharmaceutical affair monitoring agent The current status on safety information collection and process The current status on annual local drug monitoring center designation The current status on narcotics ingredients The record of biological drug manufacturing-import The top 10 manufacturing amount of cosmetics and quasi drugs The current status on clinical test approval for each items The local degree of medical device self support The current status on medical device GMP corporations divided by grade The current status on regional medical device GMP corporations The current status on medical device monitoring agent The current status on medical device honorary monitoring agent The current status on medical device civil affair process The current status on medical device technical document review-screening
Drugs (26)
Drugs (26)
The office established the foundation of food and drug statistics to promote the establishment of the KFDA Statistics Portal and development of Self-Diagnostics of Statistics Quality. It also analyzed the trend of related organizations and industry, reflected on survey requests, developed the policy statistics contents, discovered useful new policy statistics and adjusted and improved existing policy statistics to release 38 types of new statistics in 2011 Statistics Report. Meanwhile, statistics portal site will be established and launched by the late 2011. The check list was also developed to manage the quality of policy statistic, in terms of accuracy, relationships, accessibility, interpretation and consistency. In 2011, 21 types of statistics quality are to be managed by self-diagnostics and trust of policy statistics is expected to increase by resolving the improvement issues. For the major statistics, quality management conducted on an annual basis. Table 1-5-1 List of New Statistics for 2011
Field The name of new statistics The number of health functional food corporation The division of health functional food industry among the local industries Food (4) The monitoring on violation of health functional food manufacturers The monitoring on violation of health functional food distributors Medical device (8) Drugs (26)
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The office is supporting policy statistic analysis through consultations and surveys to improve the civil complaint made on the relocation project, and provided analysis data to policy establishment and evaluation in 2010. It also hosted a workshop and educational seminar with an expert to reinforce the capability of statistics management and production. The office is putting efforts to provide quality education for policy statistic the KFDA from 2011. Figure 1-5-4 Policy Statistic Education Workshop and Educational Resource
Figure 1-5-5 N umber of Clinical Statistics Application from 2009 to Early 2011
(Case) 140 120 100 80 60 40
2011 2010
20 0
Health functional food Biopharmaceuticals Crude Drugs Safety Medical Devices 2009 Pharmaceutical (Cate Products -gories)
The office is also publishing clinical statistics guidebook and holding the workshop to established the foundation for clinical statistics. One of the guidebooks published in 2010 is Data Management for Clinical Trials. This guidebook provides information in Clinical Data Management System, Case Record Form, Data Management Plan, DataBase Structure, Data Validation Specification, DataBase Quality Check, Archiving, DM Audit and etc. In 2011, Casebook of Clinical Test and Statistics for Medical Devices was published, based on the evaluation results from the clinic trials protocol and
3. Clinical Statistic
Clinical statistics of the International Trade and Statistic Officer is the statistical information that are used for clinical tests and collected information of food, drug and medical devices for their safety and efficacy. Every year, the number of test applications increase following the development of new test methods. A total of 242 cases of pre-consultation for approvals and professional statistical techniques were supported by the Office in 2010, which is 332% increase compared to the previous year. It shows the growing importance of clinical statistics. It is composed of 2 food cases, 1 biopharmaceuticals, 76 pharmaceuticals, 11 crude drugs, 119 medical devices and 32 on research protocol of safety information. The office support documents review of civil service as well as conducts research on the actual condition of clinical trials.
reports from 2010, in order to prevent often-made mistakes. This casebook covers 119 cases of 67 product items. The guide book for Statistical Consideration of Bridging Study and Casebook of Clinical Trials and Statistics for Medicine will be published in late 2011. The office held statistics workshop twice in 2010 to share and diffuse clinical statistics knowledge, and 140 persons including drug manufacturers, hospitals, clinical test centers and academia attended the workshop. The workshop of August covered the statistical considerations of clinical trials and the one on November covered Statistics of Clinical Trials for Medical Devices with the U.S. regulatory agency. The office is planning to hold a workshop for clinical statistics in late 2011, as well.
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plan 2 6 80 14 171
result report 4 30 2 58
Thus, the KFDA is doing its best to promote the importance of clinical statistics and share the knowledge by publishing guidebooks and holding the annual workshops, in order to establish the necessity and foundation of statistics for clinical trials and clinical statistics.
10
33
31
32
32
75
72
Annual total
56
41
15
242
197
45
144
107
37
442
345
97
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1. Regulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. Successful Relocation of Osong Health Technology Administration Complex 3. International Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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2. Performance
In 2003, the KFDA promoted the projects based on Information Strategic Planning (ISP) for KiFDA'. It covers 4 subjects: general service for food and drug, administration
06
portal, information sharing, and safety information service for food and agricultural, marine, livestock products. The KFDA also established ITA/ISP in 2008, in order to promote effective informatization. Table 1-6-1 KiFDA Establishment Process
Name of business
The information system on drug safety control The information system on medical device safety control Food safety portal
The establishment of KFDA information technology architecture (ITA) and informatization strategy plan (ISP) The establishment of fooddrug test-investigation national network (food area) for the sharing of test-investigation information The establishment of fooddrug test-investigation national network (drug area) for the sharing of test-investigation information The relocation of information system to Osong and establishment of informationcommunication network business
The establishment of information technology architecture (ITA) The definition of medium and long term informatization master plan and informatization strategic subject The food safety information network
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Mission
Prevention, response and support for national health and safety of food and drug
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Vision
1 Strategic Target
Preventive Risk Management System
Securing the highest level of national health by food and drug safety
2
Safety Management from Raw Material to Sales of Final Product
5
Vitalization of Communication for Safety
6
Reinforcement of Cooperation System
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IT Vision
IT Strategic Target
Establishment of IT-KFDA for safety management of food and drug based on national trust
The relocation of information system to Osong The establishment of computing office and separation of network The enhancement of user convenient feature The reinforcement of document security and security management
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Advancement of IT foundations
Improvement of IT capacity
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3. Prospect Plan
The KFDA is planning to establish the customer-focusedservice application system and improve and advance Food and Drug Safety Information Service. Figure 1-6-2 Prospect System Plans
IT Vision System
1. R egulatory Reform to Enhance the Public Assurance, Industry Activity and the Nation's Status 2. S uccessful Relocation of Osong Health Technology Administration Complex 3. I nternational Trade and Cooperation in Food and Drug 4. Reinforcement of Cooperation with Consumer Organization and Civil Affairs Administration Service 5. Policy Statistics to Manage Productions 6. Korea Internet Food and Drug Administration (KiFDA) 7. Promotion of R&D - Supporting the Safety of the Public
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Modification of information organizing system
Advancement strategy of ITA Management system for IT investment performance Modification of information organizing system
IT Vision
Advancement of IT base
Recently, attention to well-being, introduction of the aging society and low birth rate is arising, and as a response, the public are striving for increased income and improved life style. The directions of governmental research and development (R&D) projects are to provide technical assistance of digital and network, promote convergence technology, such as Biotchnology (BT), Information Technology (IT), Nanotechnology (NT) and Environmental Technology (ET), and improve of the nations quality of life. The U.S. invested 21% (32,100 million dollar) to healthcare after national defense (56.9%), out of R&D budget of 2009. China and Japan are also concentrating on BT. However, Korean R&D budget for the KFDA is 0.4% (54,300 million won) out of total (13 trillion won).
IT Strategic target
Establishment Establishment of development of strategy plan plan for safety for KFDA information development portal
Advancement of IT infrastructure
Introduction of KiFDA ll
Information sharing
IT actual project
4. Expected Effectiveness
It substantially improved the convenience of the service application, productivity and competitiveness of industry. Expected effectiveness are like the following: First, food safety system and effectiveness of Research Institute of Public Health & Environment and other food sanitation test organizations were improved by providing information of medicine and safety. Second, effectiveness of administrative service was enhanced by providing information to related department and officials. Third, safety management for medical equipment was improved through releasing evaluation result, tracking management of companys safety. Fourth, accuracy, speed, and transparency of administration were enhanced by the establishment of civil affairs administration portal. Fifth, customer centered food and drug safety culture was established by customizing the portal which provides the required information.
The KFDA is conducting researches on scientific safety management of food, drug and medical device to secure the safe and healthy life of the nation. The administration is also promoting product approvals to support prompt commercialization of BT, IT and NT products.
1. Expansion of R&D Budget for Scientific Safety Management of Food and Drug
In response to the rapid growth of food and drug safety management through the development in scientific technology, the KFDA is expanding its R&D scale to establish a new policy and scientific basis. It is showing annual growth of 4.7% since 2006. Main directions for R&D budget compilation are the following. First, improve
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productivity by promoting R&D projects. Second, introduce a flexible response system to reflect the policy in demand. Third, improve the cohesiveness of research to establish an operating base for large-scale project. Table 1-7-1 Financial Management of Major R&D Project in the Past 5 Years
(Unit: 100 million won, %)
Class Total Safety control on food Safety control on drug Safety control on biological drug
1)
2007 491.2 121.5 123.0 48.5 37.1 131.7 10.0 17.5 1.9 -
2008 519.0 139.3 122.5 49.1 37.2 131.3 20.0 17.6 2.0 -
2009 517.8 173.4 103.3 35.1 30.1 146.3 12.6 2.0 15.0
Annual increase rate of average 4.7 14.3 25.4 100.0 1.9 13.5 net increase 100.0 39.6 -
Safety control on medical device Basic research on safety control Basic research on toxicity of nano material2) Scientific approach of risk material safety control Research on international cooperation3) Research on political basis The management of researchdevelopment business
1) Consolidated to medicine safety management since 2010 2) Consolidated to Safety management research since 2009 3) Closed in 2009
Safety control on drug Safety control on drug - Research on drug safety control - Research on drug safety control -R esearch on cosmetics-quasi drugs safety - Research on cosmetics-quasi drugs safety control control - Research on active monitoring of risk case of - Herbal medicine safety control drug - Research on scientific herbal medicine - Research on international harmonization of assessment technique approval evaluation regulation - Research on advanced drug evaluation The best lab standard model development and - Research on active monitoring for side effect of - system establishment research drug - The research on biological drug safety control - The research on the assessment of vaccine usefulness - The research on high tech drug safety control - The research agency on evaluation of stem cell - The research on human body tissue transplantation material safety control - The research on the cooperation with international organization - The research on herbal medicine safety control - The research on herbal medicine assessment technique - The research on enhancement of herbal medicine evaluation system Biological drug safety control - The establishment of national standard form on biotechnological drug - The research on biological drug safety control - The research on biotechnological drug safety control - The research on the assessment base of high tech BT drug - The research on the assessment of vaccine usefulness - The research on the world health organization cooperation center Medical device-radiation safety control - Medical device safety control - Radiation safety control Integrated in (safety control on drug)
According to the structural reorganization of April 2009, R&D budget, which was divided by each subject, was consolidated as a unit project for maximized result and effective management. Also, Systematic Approach to Safety Management of Toxic Substance was distinctively organized for integrated management of toxic substances in the food and drug.
Medical device safety control - Medical device safety control - Radiation safety control - The research on U-health medical device assessment technique development
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Business system of 2009 (7 detail business, 27 small scale business) The research on safety control basis - The research on toxic material control - The research on human body effect of risk material - The research on high tech application basis - The research on nano material toxic basis
Business system of 2010 (7 detail business, 32 small scale business) The research on safety control basis - The research on toxic material control - The research on expectation assessment of drug safety - The research on the establishment of Korean clinical test-assessment basis - The research on high tech analysis technique basis - The research on nano material toxic basis - The research on the development of green toxicity assessment technique The scientific approach on risk material safety control - The research on confirmation of risk material exposure - The research on hazardous effect of risk material - The scientific approach of risk material hazard analysis
The research on international cooperation Integrated partially in (safety control on drug) - The research on the international harmonization strategy of safety control system - The research on international cooperation with international organization The research-development of policy The research-development business management The research on political basis The research-development business management
Policy Researches 756 million won (1.4%) Scientific Safety Management of Hazardous Substance 4,945 million won (9.1%)
By introducing research groups for of Safety management of childrens food and Advancement in medicine review and evaluation in 2008, and further projects on Safety management of residual pesticide, Systemic approach to herbal medicine evaluation technique, Drug observation and Drug metabolism base were initiated in 2009. In 2010, 5 more groups (7,550 million) for research on food, drugs, safety and hazard substance were created, expanding the total number of research groups to 10, with the R%D size of 16,190 million won, and taking up 30% (54,300 million won) of the total budget. The projects are progressing as below. Food safety management based on climatic
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changes project (2010~2014, 12,500 million won), Review and evaluation of stem cell medicine project (2010~2013, 5,500 million won), and Development of advanced toxic evaluation technique based of green growth and Nano safety evaluation projects (2010~2012, 3,800 million won). In addition, General exposure evaluation of hazard substance is in progress from 2010 to 2012, with 6,300 million won. Figure 1-7-2 Current Condition of Research Institutes
Safety management for childrens food (4,430 million won)
Safety management of residual pesticide (5,300 million won) Food safety management based on climatic changes (12,500 million won)
Drug observation (5,900 million won) Systemic approach to herbal material evaluation technique (9,840 million won) Review and evaluation of stem cell medicine (5,500 million won) Drug metabolism base (2,700 million won)
Development of advanced toxic evaluation technique based on green growth (3,800 million won) Nano safety evaluation base (4,150 million won)
2011
2012~
2014
The research institute is composed of large projects that are associated with medium and small projects. Hence, enhanced cooperation between projects is necessary to improve the productivity of researches. The promotion of research groups expected to maximize the productivity of research by minimizing trial and error, securing relationships between projects and establishing cooperating networks between project members, and expanding the collaborative channel between researcher and policy maker.
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evaluation. The administration also participates in the investigation and analysis of National Science & Technology Council, providing the result processed with other information from National Science & Technology Information Service (NTIS). The KFDA is also conducting self-evaluation according to plan and manual suggested by the Ministry of Strategy and Finance and receives an in-depth evaluation when requested.
The risk effect research team Health functional food standard department Medical device research department Chemical material department Ewha womens university Seoul national university The Istech Co. Ltd. The Korea instrument electricity and electronic test researcher
2) In-Depth Evaluation
Medicine safety management project received the in-depth evaluation and was subsequently selected for the provision of extra budget.
3) Tracking Evaluation
The purpose of tracking evaluation is to promote the continuedutilization of the R&D result. A total 567 projects were the subject of this evaluation in 2010.
First evaluation: 545 project of 2008 Second
Yonsei university
6. Performance Management to Promote the Usefulness of Investment for Research and Development Project
Performance Management to Induce Investments in R&D Projects According to the properties of R&D projects that provide the scientific basis for safety management policy, the KFDA should focus on the policy utilization for planning, management and academic involvement. Also, it conducted self-management, analysis and tracking
evaluation in 2009 - Third evaluation: 2 projects of 2006 that received Insufficient during the evaluation of 2008 For those 12 projects that were evaluated to be Insufficient were demanded to submit the backup plans, and will receive the second tracking evaluation in 2011.
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Chapter 02
Risk Prevention
01 Food and Drug Risk Prevention and Dissemination of Safety Information 02 Integrated Control System of Risk Information and Reinforcement of Analysis Capability 03 Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
1. Food and Drug Risk Prevention and Dissemination of Safety Information 2. Integrated Control System of Risk Information and Reinforcement of Analysis Capability Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations 3.
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01
The KFDA prepared an emergency response manual that outlines various action plans against possible emergency scenarios to prevent further spread of the crises and minimize public damage when faced by real food and drug safety emergencies. The manual identified 4 levels of emergency situations, defined as Attention (Blue), Caution (Yellow), Alert (Orange) and Serious (Red), and characterized appropriate directions according to each situation to minimize formality and unnecessary procedures, and establish an action plans that can be utilized at the scene of the accident. The KFDA is organizing regular mock trainings with the Office of the Prime Minister, Ministry of Health and Welfare, and the local governments. The training aims to develop smooth operational procedures to improve emergency response capability and establish a synergistic cooperation system with related departments based on the provided guideline. The KFDA have also organized a specific training program for staff members of the KFDA, and the City and Provincial Government. Figure 2-1-1 The Mock Training for Emergency Action (Food and Drug)
Foods and drugs are the critical resources in peoples lives, and securing their safety is the most significant factor in maintaining national health. In a modern world, owing to the development of science, new hazardous materials are being discovered in nature or from cooking and processing procedures. These materials have risks that are difficult to predict, and their treatment methods are equally complex. Therefore, the problem-solving approaches used in post-management, such as monitoring and inspection, are limited in the provision of proper direction of policies. Moreover, due to the globalization of food trade caused by the development in the mode of transportation, the increasing possibilities in the production and distribution of hazardous food and awareness of people on foods and drugs safety caused by the enhancement of living standards are resulting in greater expectations for highly reliable safety control system. Hence, rapid changes in the internal and external environment of food and drug safety, and the increasing concerns of the public. This required the KFDA to establish a preventive foods and drugs safety control system to prevent safety incidents of foods and drugs. To address these sociological requests, the KFDA has established a risk prevention policy bureau to prevent of food and drug safety incidents and take immediate actions upon their occurrence. The KFDA aims to prevent risk through examination and distribution of a wider range of risk information on domestic or foreign foods and drugs. It will also focus on the prevention and cooperative actions on their safety incidents, and provide risk information to related business operators. The KFDA also reinforces bi-directional communication among the consumers to prevent risk caused by inaccurate information.
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and foreign governments and mass media. The KFDA also analyzes and evaluates the seriousness and urgency of the collected information and directs appropriate actions to secure the safety of domestic and imported food. Most importantly, the KFDA shall review intervention and control methods, such as prohibition of import or sale or distribution of food when an immediate action is required. This is to prevent food safety incidents in advance. In 2010, the KFDA performed an investigation on veterinary drugs, pesticide residues, food poisoning bacteria, heavy metals, food additives and substances produced from manufacturing processes in agricultural products, processed foods, and processed marine products. The investigation found 5 cases of abnormal pesticide residues from crown daisy and red-pepper leaf. The KFDA directed administrative actions, and suspended and seized the products to prevent further issues. Table 2-1-1 Current Preliminary Investigation Status
2005 Cases 916 2006 1,364 2007 1,453 2008 1,648 2009 474
(unit: case)
2010 834
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quite distinct. Hence various consumer-focused communication efforts are needed to obtain the publics trust. It is equally critical to establish a concrete safety management system for foods and drugs. The KFDA has been reinforcing communications with the public through the establishment of a basic project on risk communication strategy in October 2010. The aims are to eliminate divergent views among the specialists and the general public, and gain public confidence in food and drugs safety management policies.
Table 2-1-3 The Subjects of The Open Forums of Foods and Drugs Safety in 2010
Date Subject The new standard of heavy metal (cadmium) in herbal medicines (scheme) The risk assessment to suggest standard of cadmium in herbal medicines The standard of cosmetics and improvable remedy of the test Understanding of pesticides The actual condition of domestic residual pesticide safety control and risk communication Understanding of radiation irradiation The actual condition of irradiated food control of industries
2) The Open Forum on Foods and Drugs Safety to Communicate with the Public
With recent foods and drugs incidents/accidents becoming large scale and expectations on governments safety management level increasing, the need for risk communications of foods and drugs safety issues has increased too. The KFDA organized The Open Forum on Foods and Drugs Safety, to provide opportunities for communications and discussions on the policies between the interested parties such as consumers, producers, academia, and government to manage environmental changes efficiently. The KFDA hosted a total of 43 open forums between 2006 to 2010, in which 5,764 people participated. In 2010, four different forums with different themes, such as The Requirement of Improvement and Improvable Remedy of the Current Standard for Cadmium, The Standard on Cosmetics and Improvable Remedy of Tests, Understanding of Pesticide Residues, and The Views and Opinions of Specialists on the Safety of Irradiated Food were held. Figure 2-1-2 The Open Forums of Foods and Drugs Safety
3) KFDA Open Day, Welcome to Osong! an Opportunity to Communicate Directly with the People
KFDA Open Day, welcome to Osong! is KFDAs visiting program organized every month since February, 2011, for the members of the general public, such as housewives, who are interested in foods and drug safety management. This program demonstrates and converses on how food and drug safety management is conducted. The visitors can experience the KFDAs responsibilities by visiting various laboratories and participating in experiments. The visitors are also given an opportunity to visit a related industry to experience how safety managements are being carried out in industrial settings. Figure 2-1-3 The Participants of KFDA Open Day, W-elcome to Osong!
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Figure 2-1-5 KFDA Young Leaders in Food and Drug Safety Day Camp
4) T he Appointment of a KFDA Young Leaders in Food and Drug Safety to Communicate with the Next Generation
The proper understanding of foods and drugs by youths, who are still establishing their values in life, is particularly beneficial because it is directly connected with the health of the future society. The KFDA is operating a program called KFDA Young Leaders in Food and Drug Safety as a method to invigorate the communication with the next generation. The KFDA Young Leaders not only share food and drugs safety information in their perspective but also communicate to friends and family to lead changes in their perception. Young leaders of food and drug safety are divided into small teams, where they share their knowledge with friends, neighbors, and with people online through the promotion of creative advertising activities for 2 months. The KFDA will regularly provide information and update news even after the termination of their activity period as young leaders, for them to maintain future activities on their own. With this type of program as a start, the KFDA will continue to host different activities to inform future generations.
Figure 2-1-6 Young Leaders Participating in the Viral Test for Hands
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1. Food and Drug Risk Prevention and Dissemination of Safety Information 2. Integrated Control System of Risk Information and Reinforcement of Analysis Capability Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations 3.
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The online risk information collection and analysis of foreign and domestic food and drugs of 2010 is shown in [Table 2-2-1].
02
Table 2-2-1 Status on On-Line Information Collection and Analysis of Domestic and Foreign Food & Drug Information
Year Number of food information Number of drug information 2003 1,776 2004 1,454 2005 2,912 2006 4,621 2007 5,224 2008 8,144 115 2009 15,541 6,916 2010 19,278 7,085
In 2010, the KFDA enhanced the collection and analysis of safety information through methods such as utilizing both online and offline information sources, to establish anticipative prevention system. The KFDA also focused in establishing rapid information exchange and distribution system. As examples of online information sources, the KFDA expanded its key word searches (63) and site searches (335) with the consideration of imported and rejected foods and drugs statistics. It also reinforced the information collection system by increasing the number of specialized editors to obtain information from international organizations, government authorities and news media. For offline information, the KFDA is utilizing foreign information reporters, dispatched workers in diplomatic offices, network between related organizations, and contact channels of foreign information sources.
Medicine, medical device and cosmetic information begin from December 9th, 2008
The collected information is shared with related KFDA departments or external organizations after the analysis and assessment processes. If required, the KFDA will take immediate response to the given information. In 2010, the KFDA gathered and analyzed 26,363 online information, and directed inspection of import or distribution processes, made changes in approvals of admission and sent out safety warning letter when deemed necessary. By supporting rapid risk prevention information collection and distribution of foods and drugs through comprehensive sharing system, the KFDA is also focusing on active communication with the public. Figure 2-2-2 R isk Information Flowchart
Online information
Offline information
Foreign information reporters International organizations Foreign/domestic government authorities Foreign/domestic consumer organization,
special organizations Foreign/domestic news medias
Diplomatic offices
(international students)
Consider magnitude of damage, import condition Analyze similar case in the past
Information Analysis
Information gathering
Foreign/domestic network
Integrated information
Remedial action
Information sharing
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1. Food and Drug Risk Prevention and Dissemination of Safety Information 2. Integrated Control System of Risk Information and Reinforcement of Analysis Capability Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations 3.
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test/inspection organizations. The KFDA will authorize advanced national test ability and remove risk factors of test/inspection organizations.
03
Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
Figure 2-3-1 The Step by Step Distribution of Advanced Operation System for Test/Inspection Organization
1st step (2010)
Develop of models for food sector and conduct trial operations (8 organizations)
1. Introduction of an Advanced Operation System in Foods and Drugs Test and Inspection Organizations
The test/inspection organization functions as a safety device for imported and distributed foods and drugs. Therefore, their objectivity and reliability are essential. In these days, the demands of the introduction of advanced test system are increasing to improve test reliability and international harmony of test/inspection organization due to the increasing possibilities of a trade dispute on test results of international trade goods caused by changing of international trade environment such as the FTA.
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Chapter 03
Food
01 Preventive and Scientific Management Infrastructure of Food Hazards 02 Securing Health by Food and Nutrition Management 03 Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 04 Establishment and Operation of Food Safety Information Center 05 Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
1. Preventive and Scientific Management Infrastructure of Food Hazards 2. Securing Health by Food and Nutrition Management 3. Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. Establishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
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Food
01
Result of pre and post analysis of the companies that applied HACCP showed an increase in sales and a decrease in customer complaints. Table 3-1-1 Result of HACCP Application of Food Manufacturing and Processing Companies (100 Companies)
Item Average Differences Rate of Increase/ in Sale Decrease (+/-) 277 million won +63% 191 million won 10,847 million won 6,833 million won 267,103 ton 236,507 ton 22 place 478,759 ton 348,892 ton - 10 cases +32% +64% +71% +69% +88% +18% +91% +106% -74%
1. Activation of Food Safety Management - Hazard Analysis Critical Control Point System (HACCP)
1) Concept and Necessity of HACCP System
Hazard Analysis Critical Control Point is a comprehensive food safety management system that confirms and analyzes all the potential hazards through managing raw materials and every procedure involved in food production. Figure 3-1-1 The Structure of HACCP
Total Total of Approved Item Total Financial Sales Total of Approved Statements Item Total Production Output Total of Approved Item Suppliers Condition of Total Sales Amount of Supplies Total of Approved Item Sanitary Index Number of Complaint Net Profits
cost efficiency analysis according to HACCP approval
As HACCP approved food range increase, food safety incidents will be reduced,
Analysis of potential physical, chemical, and biological hazards in raw materials and manufacturing processes
HA
Hazard Analysis
CCP
Critical Control Point
Focused management on manufacturing processes or phases to eliminate or reduce hazards to an acceptable level.
providing a better selection of safe food choices for consumers and assuring them in food safety.
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Food
to protect the national health by securing the safety of food of high risks or in high demand. In 2003, 6 food types were designated for mandatory application of HACCP (7 currently, after adding Cabbage Kimchi in December, 2006). In October 2005, HACCP regulation was amended to initiate phased introduction of mandatory HACCP from 2006 to 2010 for another 6 food types with the consideration of annual sales and employ numbers of food businesses (cabbage kimchi began in April 2008 and to be completed by 2014). Table 3-1-2 Implementation of Mandatory HACCP Approval, by Food Items
State 1 2 3 4 Criteria More than 2 billion won of annual sales and more 51 employees More than 500 million of annual sales and more than 21 employees More than 100 million of annual sales and more than 6 employees Less than 100 million or less than 5 employees Date of Implementation Date of Implementation for 6 Items for Cabbage Kimchi December 1, 2006 December 1, 2008 December 1, 2010 December 1, 2012 December 1, 2008 December 1, 2010 December 1, 2012 December 1, 2014
total
subtotal
Group Group Catering Catering Service General Non Service Selling Ice- Frozen Fish Retort sub- HeatFrozen Cabbage Products Food cream Marine Cake Pouch total Treated Products Kimchi Products Products Products Products Products Mandatory HACCP Approval 534 9 34 226 71 51 24 119 593 24 2
1,253
1,127
In 2010, the KFDA revised the HACCP standard to HACCP management standard for small companies to support easier approval and participation, and distributed the standardized management standard form for product types. Also, onsite technical assistants were increased by 22 (from 21 to 43) in order to provide HACCP support responsibilities (December 2010). In 2011, to expand participation for small companies, the KFDA will shorten the time taken to process of customer inquiries (60 to 40 days), reduce the required documents, allow the small company that requires optional approval to apply the Management Standard for Small Companies, and facilitate an easier approval for restaurant businesses. It is also planning to accomplish post management of HACCP approval, carrying out the routine observation on HACCP approved companies and the Food Sanitation Act violated companies. The KFDA is promoting various support activities for small and medium sized companies by establishing the HACCP Support Agency in the Korea Health Industry
Expansion of HACCP Application became a goal for the administration in 2008, and Comprehensive Measures for Food Safety of the Korean goverment also selected above goal as a main task. The KFDA is aiming to approve 4,000 food businesses by 2012. Up until now, the number of approved companies was significantly raised from 69 places in 2003 to 1,153 places in 2010. Figure 3-1-2 Number of HACCP Approved Company by Year
500 400 300 200 100 0
3 3 2 28 8 6 24 16 31 9 64 35 92 35 111 29 152 45 225 337 475 726
Unit: case
1,153
Development Institute since 2007. In 2010, the KFDA examined the condition of HACCP preparation, supervised techniques and began to train HACCP approved small and medium sized companies on efficient post management strategies. As the result, the average customer satisfaction of 2010 rose 83.9%. In 2011, the KFDA is planning to improve the support for small and medium sized companies by allowing them to receive the HACCP approval easily through technical support and expert consultations, and develop and distribute of HACCP management standards that can be used in optionally approval items.
Accumulated amount
Designation
78
122
146
263
456
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 (On December 31, 2010, 1,153 places were approved (534 mandatory, 619 optional)
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Food
Preparation Stage
Approval Stage
Decrease in 2009 due to the promotion of sanitation with swine flu endemic
Case
271
126
27 677
19 372 Virus
18 223
14 401
5 171 Chemicals 1 3
28 1,926
For a successful establishment of the HACCP, the consumer should prefer and choose HACCP approved items for food businesses to recognize such needs. Therefore, the KFDA is promoting the importance of HACCP to the public every year. In 2010, the KFDA diversified the advertising media to TV, subway advertisements, internet banners and HACCP proved company visiting programs. The HACCP awareness of consumers grew from 9.7% in 2005 to 30% in 2010, and the environment for voluntary HACCP application by food businesses is being established. The plan for 2011 is to reinforce TV and subway advertisements and diversify methods of advertising through budget increases.
Norovirus 31 1,994
Other 2 8
Immediately following the massive school food poisoning incident in 2006, patients of group catering service were temporarily decreased as sanitary monitoring was strengthened, but patient numbers are increasing again gradually
Patient rate of group catering service: 46.8% (2007) 48.3% (2008) 57.3% (2009) 58.0 % (2010) N umber of patients per single school incident: 54.5 (2007) 76.5 (2008) 69.6 (2009) 89.2(2010) N umber of food poisoning patients is 143 out of a million, similar to Japan. K orea: 201 (2007) 154 (2008) 123 (2009) 143 (2010) Japan: 263 (2007) 191 (2008) 159 (2009) 174 (2010)
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Food
According to the 2010 trend of food poisoning outbreak by month and location, 51% of outbreaks and 55% of patient occurred in the summer (June to September). Table 3-1-6 Food Poisoning by Month
Janu- FebruMarch April ary ary Cases Patients 9 142 17 430 15 364 20 893 May 15 201 June 29 1,908 July August 34 561 41 770 Septem- Octo- Novem- December ber ber ber 35 783 18 335 15 362 232 469
49.6% out of whole food poisoning incidents occurred in restaurants when sorted by locations, and 58.5% out of whole patients were found in group catering services. Table 3-1-7 Food Poisoning by Locations
Group Food Service Total Subtotal 53 4,189 79 School Direct 30 2,770 92 Consignment 8 620 78 Business 15 799 53 Restaurant Other*
Cases
271 7,218 27
133 1,704 13
85 1,325 16
41 35 23
Salmonella poisoning by eggs in gimbap (seaweed rolled rice) and meat in precooked foods occurred most often (20 cases, 15%), and Norovirus poisoning was usually occurred at school and business. Figure 3-1-6 Food Poisoning at the Group Catering Service
(Case) 60 50 Consignment Direct
1,000 500 0
430
893
6 7 Month
335
10
11
12
Business 15 Consignment 7
30 20 10 0
School 38
7
Direct 31
7 Primary School
45
500 0
2006
2007
2008 Year
2009
2010
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Food
Figure 3-1-8 C urrent Condition of Enteropathogenic Escherichia Coli Outbreak per Month
(Cases) 10 9 8 7 6 5 4 3 2 1 0 Cases Patients (Patients) 900 800 700 600 500 400 300 200 100 0
Bacillus 1 case(4%)
Campylobacter 3 cases(12%)
6 7 Month
10
11
12
Norovirus caused the most poisoning incidents, and the rest were like the following - Enteropathogenic Escherichia coli > Salmonella > Staphylococcus aureus > Vibrio Parahaemolyticus Table 3-1-8 The Foodborne Disease Break Status According to Causing Material in 2010
Pathogens Non-Detection Norovirus Enteropathogenic Escherichia coli Salmonella Staphylococcus aureus Vibrio Parahaemolyticus Bacillus Cereus Campylobacter jejuni Other virus Natural toxin Chemical Number of Cases 105 31 29 27 19 18 14 15 2 6 1 Rate of Cases 38.8 11.4 10.3 9.4 7.0 6.6 5.2 5.5 0.7 2.2 0.4 Number of patients 1,030 1,994 1,896 677 372 223 401 380 8 33 3 Rate of Patients 14.3 27.6 26.7 9.4 5.2 3.1 5.6 5.3 0.1 0.5 0.04
School 1,220 persons(64%)
In summer, poisoning at the schools group food service caused by Enteropathogenic Escherichia coli was increased, and Salmonella poisoning was constant occuring throughout the year except for the winter season.
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Food
School 0 persons(0%)
Norovirus has the characteristics to occur more frequently in winter, but 702 persons were poisoned in June, 2010 at schools, which is a different trend when compared to Japan. Figure 3-1-12 Norovirus Poisoning in Korea
Number of Patients 800 700 600 500 400 300 200 100 0 1 2 3 4 5 6 7 Month 8 9 10 11 12 2010 2009 On average of 3 Years (06~08)
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Food
1. Improvement of Instruction and Advertisement for Food Poisoning Prevention Instruction, Examination and Advertisement for Cafeterias of School and Kindergarten - Examination of Cafeteria of Schools (including Kindergartens) - Improvement of Old Cafeteria (continuously) - Expansion of Freezer for Preserved Foods Only Advertisement and Instruction for Cafeteria of Penitentiary - Broadcasting the Video for Food Poisoning Prevention - Instruction of Prevention Management for Correctional Institutions Workshop to Amend Prevention Management and Manual for Food Poisoning and Infectious Diseases Instruction, Examination and Advertisement for Cafeteria of Conscripted Police and Riot Police Prevention Check-up Service with Expert
At all times
Ministry of Education
At all times
Ministry of Justice
2. Establishment of Examination and Management System for Norovirus Improvement of Management for groundwater using Facilities and Inspecting for Pollution Source - Expansion of Groundwater Measurement Network (40 places in 2009 58 places in 2010) - Promotion of Small Water Supply Plant Improvement Project (657 places in 2010, government subsidies 573,000 million won) Improvement of Management System for Underground Norovirus - Examination of Norovirus Condition of Groundwater Pipes Examination and Improvement for Burial Site Foot-andMouth Disease Infected Animal - Examination for Influence from Burial Site of Foot-andMouth Disease and AI Infected Animals (23 places - 15 AI Burial Sites in 2008 - 2011 and 8 Foot-and-Mouth Disease Burial Sites in 2011) Norovirus Examination for 29 Beaches of South-west Coasts - Every Other Week of September, 2010 ~ April, 2011 Expansion of Prevention Facilities for Oyster Farm - Portable Toilet Dissemination and Examination for Incineration Toilet Instruction and Education of Fishing Industry for Prevention
At all times
Ministry of Environment
Yearly
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CHapTEr 03 1. P reventive and Scientific Management Infrastructure of Food Hazards 2. S ecuring Health by Food and Nutrition Management 3. P reparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. E stablishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
Food
Main Project N orovirus Examination of Group Food Service Facilities using Groundwater - Group Food Service Facilities of School, Training Center and Social Welfare Organization - 18 cases out of 2,293 cases (Equipment Improvement and Sanitation Management of Detected Facilities) E stablishment of Examination System for Norovirus - Expansion of Water Sampling Equipment - Development of Examination Subject 3. Improvement of Safety Management for E xpansion of History Traceability System for Agricultural, Marine and Livestock Spot Examination of Food supplier
Schedule
Department (Organization)
At all times
KFDA
02
Ministry for Food, Agriculture, Forestry and Fisheries KFDA and Local Government
4. Support for Group Food Service Facility of Food Promotion Fund E xpansion of Food Service Facility Support - Freezer for Preserved Foods Only Support for Weak At all times Sanitation Facilities 5. Collection and Analysis of Food Poisoning Information and Share Operation of Alert Notification System Expansion of Publishing System for Violated Company At all times At all times
1. Management of Nutrition with Potential Risks: Sugar, Sodium and Trans Fat
1) Background
Obese society is expected to cost a total 1,800 billion won through direct and indirect medical expenses (1,100 billion won and 700 billion won, respectively). Childhood obesity is growing rapidly with the possibility that 40% of child obesity and 70% of teenager obesity would leave to adult obesity. Hence, it is necessary to establish the environment that protects children from obesity.
Local Government
6. Improvement of Cause Investigation P rofessional Education Course for Food Poisoning Instructor(4 times, 109 persons) P rofessional Education for Examination - Setting up and Operation of Education for Examination At all times KFDA Course (February, May, September) I mprovement of Investigation by Gene Analysis. - Pulsed Field Gel Electrophoresis (PFGE) Analysis. Guideline Revision of Epidemiological Investigation for Water Born Infection. - Supporting the Prompt Field Investigation Centers for Disease Improvement Promotion for Cause Pathogen Investigation At all times Control and Prevention - 15,000 sets of Excrement Collecting Kit Distribution Improvement of Epidemiological Investigation Partys Capability 7. Improvement of Food Poisoning Prevention Education and Advertisement E ducation and Advertisement for Nation - Promoting Advertisement on TV(May~June) - 101 times May~June, KFDA on KBS, MBC, SBS 2011, Ongoing P revention Education Customized for Subject and Time Improvement of Hand Washing Project for Group Food Service Facilities - Expansion of Sink, Soap, Paper Towel and Hand Disinfectant - Water basin for Restaurants - Improvement of New Food Service Facility Ministry of Education, Ministry of Health and Welfare, And KFDA
(1) D evelopment and Distribution of Guideline and Q&As for Nutrition Labeling at Restaurants
According to implementation of Special Act for Safety Management of Childrens Diet, Regulation on Nutritionl Labeling and Method for Childrens Food was established. Therefore, Nutrition Labeling guideline and FAQ for Nutrition Labeling were also published to help the food industry. Many types of educational materials were developed to increase the publics awareness of nutritional labeling.
At all times
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Figure 3-2-4 S urvey of Awareness for Nutrition Labeling at Jukjeon Rest Area
(3) P romotion of Nutrition Labeling for Express Way Rest Areas (March 29, 2010)
Pilot project for the implementation of Nutrition Labeling System for Food at Express way rest areas The KFDA and Korea Highway Corporation designated Jukjeon Rest Area (Gyeongbu Expressway, Northbound Lane) as the Nutrition Labeling Specialized Rest Area, providing nutrition content information for 100 products. From surveying 3,000 visitors, 90% showed satisfaction, and 89% requested its expansion to the whole country. The KFDA is to continue further expansion and management.
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Figure 3-2-5 Result of the Survey of Awareness for Nutrition Labeling at the Rest Area
Degree of Satisfaction for Nutrition Labeling Normal(10%) Not Satisfied(0%) Not satisfied at all(0%) Expansion of Rest Area Nutrition Labeling Normal(5%) Not Necessary(1%) Uninterested(3%) Non-Response(2%) Really Necessary(32%)
Satisfied (49%)
Very Satisfied(41%)
Necessary(57%)
Expansion of Voluntary Nutrition Labeling to All Major Rest Areas (July 16, 2010) All major rest areas of expressways are parts of the pilot project for the implementation of the nutrition labeling system. The KFDA and the Korea Highway Corporation is conducting the campaigns - signboard hanging ceremonies for 7 rest areas, teaching how to read the nutrition labels, and distributing food poisoning prevention materials and are planning to expand this system to 100 rest areas. Figure 3-2-6 Event of the Korean Highway Corporation (Yeoju Rest Area - Gangneung Bound Lane)
80% 60%
45%
69%
40% 20% 0%
31% 14% 1% 1% 6% 0% 5% 0%
0.2~0.5g 0.5~1g
2005
2006
2007
2008
2009
2010
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Table 3-2-1 Trans-Fat and Saturated-Fat in Domestic Processed-Food (30g per Serving)
Division
Trans fat
2005
Average
2006
Average
2007
Average
2008
Average
2009
Average
Strategic Management Gropu for National Nutrition, comprised of industry, government and academia, expanded and produced Nutrition Database for technical assistance of calorie counters and developing and distributing the Calculation Program for Nutrition Indication To provide nutrition service that the nation can refer to, Calorie Coordinator, a customized nutrition evaluation and management program for mobile technology and website was developed. The Calorie Coordinator was downloaded 103,531 times by December, 2010 and 76% of users were satisfied. Nutrition evaluation and management programs are being improved. Figure 3-2-8 Establishment of Calorie Counter Environment System
Range
Range
Range
Range
Range
Range
0.90.7 0.0~2.9 0.50.5 0.0~2.4 0.10.1 0.0~0.5 0.10.1 0.0~0.5 0.10.1 0.0~0.3 0.10.1 0.0~0.3 3.31.2 1.3~5.9 4.21.4 1.4~8.7 3.91.0 1.3~5.5 4.11.4 0.8~5.8 4.11.2 1.0~6.8 3.61.1 0.3~5.7 1.00.8 0.0~2.4 0.60.5 0.1~1.4 0.20.1 0.0~0.3 0.10.0 0.0~0.3 0.10.1 0.0~0.3 0.10.1 0.0~0.2 4.21.5 2.4~6.8 4.21.2 2.8~6.3 3.91.4 1.1~6.2 2.81.3 1.3~8.2 4.21.1 1.8~6.4 4.21.1 1.8~6.4 0.30.5 0.0~2.5 0.20.4 0.0~1.8 0.00.0 0.0~0.2 0.10.1 0.0~0.2 0.10.0 0.0~0.2 0.10.0 0.0~0.2 3.41.4 0.7~6.0 3.71.3 0.6~6.7 3.21.8 0.4~8.9 3.41.3 0.2~5.9 2.41.2 0.6~5.1 2.41.0 0.4~4.4 0.70.4 3.60.5 0.40.2 4.00.3 0.10.1 3.70.4 0.10.1 3.61.2 0.10.1 3.5 1.4 0.10.1 3.2 1.3
Biscuit
Chocolate saturated
fat Trans fat
Snack
Average saturated
fat
= standard deviation
The KFDA, related departments, industries, academia and associations held a conference to establish basic strategy for the reduction sodium intake. Also, a detailed plan was created to decrease sodium intake, composing the task force in 4 areas: food service, restaurant, processed product and education-advertisement. The KFDA is planning to promote the policy for reduction of sodium intake.
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Satisfied(45%)
The survey targeted 7,000 students from middle and high school. The result showed that 10.5% of males, 14.8% of females had High Risk Eating Disorder. To prevent the nutritional unbalance of eating disorder, High Risk Eating Disorder Prevention Program was developed and tested in a middle school. The result of this project is to be analysed in 2011.
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Total
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children and parentss right of choice and induce the manufacturers to improve their product voluntarily. Thus, manufacturers can indicate the quality certification mark on the container or packaging if their products are confirmed to meet the regulation for food additives. 29 items of fruits and vegetables juice and ice cream received the quality certification by December, 2010.
7) Installation and Operation of Management Support Center for Childrens Food Catering Service
Along with the recent drop in birth rate and increase of double-income families, expectations have risen for food safety and nutrition management of childcare facilities. However, management for group food catering service has been insufficient, becoming one of the social issues. Therefore, Management Support Center for Childrens Food Service will be installed and operated in local governments, to support food safety and nutrition management of childcare facilities such as preschools and kindergarten,
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CHapTEr 03 1. P reventive and Scientific Management Infrastructure of Food Hazards 2. S ecuring Health by Food and Nutrition Management 3. P reparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. E stablishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
Food
where there is no obligation to employ an expert. The KFDA is planning to secure the government support budget to install Management Support Center for Childrens Food Service in the 6 local governments and 10 autonomous districts. As installation and operation of Management Support Center for Childrens Food Service expands, it is expected to improve sanitary condition of group food catering services and nutrition management of childcare facilities and kindergartens.
03
1) Outline
were exposed.
Preparing the Organic and Systematic Safety Management from Raw Material to Consumption
35,403 companies, where they handle holiday seasonal food, summer seasonal food, school cafeteria, food supplier and kimchi-making seasonal food, were investigated over 6 times by the joint enforcement in 2010, and companies in violation 1,535 (4.3%) Also, to collect and examine distributed food efficiently, collection and examination on sanitarily vulnerable areas (place) was expanded. 312 food groups, 219,910 items of agricultural, marine and livestock product (including health functional food) were collected and examined, and 1,645 items (0.7%) were confirmed as unsuitable. These items were subjected to real-time disclosure of information, prompt sales blockage, recalls, and discard. Automatic sales block system for unsuitable product (food) was developed with the cooperation between private (Distribution Company) and government agencies (Ministry of Knowledge Economy and the KFDA) and uses product codes to find incongruent food. So far, 24,092 places, including 17 large and middle sized distribution companies, stores and army welfare centers, autonomically participated, providing safe consumption conditions to 1,163 persons on a daily average and contributing to prevention through promptly blocking distribution and sales. Efficient examination and management were implemented by establishing the Regulation for the Scale, Investigation and Procedures of Foreign Substance (January 4, 2010) in order to have the companies report the customers dissatisfaction for
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foreign substances. In addition, post management system was switched to pre-management systems that stop the distribution and sales to evaluate and announce the result, as means of promptly blocking the incongruent products.
to the record of the past 9 years, the number of food products unsuitable for sale is decreasing.
2) Joint Inspections
The KFDA annually carry out joint inspections on the businesses, including manufactures, processors, distributors, transporters for food, with local government and the Ministry of Education. Table 3-3-1 History of Joint Investigations
Year 2010 2009 2008 Number of Company 35,403 9,714 26,574 Number of Caught Company 1,535 525 547 Rate of Violation (%) 4.3 5.4 2.1
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Distribution company
Prohibition of Sale
Food safety management organizations implement collection and examination and report hazardous food to the Urgent Report System of the KFDA. Then Korea Net of KCCI sends the information to the POS of its member company to stop the sales. Purchase blocking
(3) E stablishment and Operation of Customer Complaint Center for Food Safety
Hazardous Food Complaint Center is where customers reports are received and handled through 1399 Call. Its mail and visiting are linked to the homepages of local FDA, cities and provinces as a banner in March, 2008, improving the system for consumer reporting. In 2010, the system was improved to transfer the reported complaints through the information sharing and examination system, and took care of 7,697 cases.
SMS
Related organizations
Prompt recalls
TV subtitles
TV programs
SMS
Stationery stores and small and medium merchants consumer organizations homepages of 1 6 cities and provinces.
Sales prohibition
On February 6, 2009, the Food Sanitation Act was amended to legislate it as an obligation that the company reports complaints to the local government if it receives the complaint from customers for foreign substances, in order to prevent the recurrence of foreign substance incidents and solve the trouble and distrust between
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customer and company. As means of preparing examination by stages of purchase, distribution and manufacturing, and improvement measures based on scientific examination for accurate causal analysis, detailed examination method and causal analysis for customers complaint were established in scientific measures. The KFDA shared standardized examination techniques and guidelines with the relevant agency and quickly resolved the company reports and customer complaints in 9,882 cases for foreign substance. It also resolved the public's concern by the improvement of manufacturing facilities and the prevention similar cases from occuring again.
183,109 document inspection (62.3%), 25,974 sensory inspections (8.8%), 59,431 detailed inspections (20.2%) and 25,474 random sample inspections (8.7%) were carried out on import foods to protect Korean consumers.
3) Achievements in 2010
The KFDA conducted onsite inspections on 33 exporting companies in 7 difference countries, including China, Thailand and Vietnam, to secure their sanitary management. The KFDA registered foreign manufacturers of 15 import items (imported through 7 different domestic importers) as outstanding foreign manufacturers after conducting onsite inspections. The KFDA conducted an in-depth analysis for hazard information and import product rejection history of domestic and foreign government organizations, such as CODEX and FDA, to prohibit the importation of food with potential hazards (pork contaminated by animal drugs, ractopamine and salbutamol, and unapproved genetically modified
Document inspection
Sensory inspection
Detailed inspection
Return or discard
Rejected
Result
Conformed
Custom clear
rice). Safety Management Information System for Imported Food was published to provide inspection information in real time, promoting the advanced safety
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management for imported food. In addition, the KFDA and Korea Customs Service signed the MOU (memorandum of understanding) to improve the cooperative system with related organizations, conducting efficient management and simplification of customs clearance. The KFDA and Korea Customs Service also combined their database into a single program (UNIPASS, September, 2010)
(1) P reparing the Foundation of Safe for Export at the Exporting Country
Onsite examination will be improved to confirm the sanitation condition of manufacturers of major exporters and the pre-confirmation based registration system will be implemented. MOU will be signed with exporters, to improve the safety management from the originating country.
(2) O perating the Prompt Response System to Exchange International Safety Information
The KFDA will be actively collecting relevant information through monitoring major international information sources, oversea monitoring agents and foreign food safety organizations, to analyse and direct measures to secure the safety of imported food.
4) Achievements
The meeting with alcohol companies and related organizations was held (July, 2010) after the signing of MOU, to explain the reason of transfers and prospects, and conducted safety management inspections and examination for 89 alcohol
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manufacturers (August, 2010) to impose corrective actions. A briefing session for foreign substance was held (September, 2010) with manufacturers of beer and Soju, made by dilution of spirit, to introduce and educate the foreign substance management. Also, safety management instructions and examination for 56 small beer manufacturers was provided and directed administrative actions for violated companies.
has provided 26,891 general information and 480 professional information, supporting the administrative actions of the KFDA.
5) Prospect Plan
The KFDA will establish the comprehensive plan for alcohol safety to conduct systematic safety management. Comprehensive plan for alcohol safety covers the technical assistance, including sanitation management for manufacturing and toxic substance and foreign material reduction, providing safe alcohol to customers and inducing the manufacturer to manufacture quality products.
3) Prospect Plans
(1) Collecting, Analyzing and Providing the Food Safety Information
The center is planning to promote the integrated management of information by operating a database and establishing an analysis system for customized information services, providing the latest (urgent) information, professional (advanced) information, hazardous food information and customer information, as required. It is also planning
to operate an information portal for food safety (Food Nara), to promote customer and consumption life centered information service.
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Supplementation of Raw Material Content Standards, When the Name is Used on the Name of the Product The products, which use the certain raw material as its name, have to label its content on the frontside. (i.e : Apple Juice (Apple 20%)) Prohibition of Using Word Flavor or Photos/Images of Indicated Food if the Product Contains Flavoring Agent If the product is flavored only by flavoring agent, it cannot use the picture or drawing of the real material. If it uses the flavor name, it should need to use the word flavor in the size of the product label, and indicate ~ Flavor Added or food flavoring agent added around the product label (example : strawberry flavor candy (synthesized strawberry flavor added) and cannot display a picture of a strawberry) Obligation of Labeling the Customer Complaint Call Number 1399 All of the products have to indicate Call 1399, for the unsanitary food for consumer convenience. Indication of Original Equipment Manufacturing (OEM) on Imported Food Packaging of OEM imported food is labeled in Korean, making customers misunderstand it as the Korean product. Therefore, the package is to indicate the country of origin and OEM size of at least 1/2 of the label.
2) Improvement
To minimize the burden of industry and wasted resources by frequent revision of labeling regulation, Combination Operating for Enforcement Date of Food Labeling Regulation released. Thus, regardless of the amendments made to labeling regulation, the enforcement date will be only once, on the same day every year. Also, regulations for glass kitchenware were introduced, and food additives labeling was simplified
3) Main Achievement
(1) 2007~2008
Reasonable Improvements to Set the Scope for Per Serving for Nutrition Labels The necessity to establish the scope of single serve was discussed, and regulations were revised to indicate the serving amount per 1 time for the products that are packed all together and packed separately. The product that is packed for one person needs to label its whole net contents per single serve. Obligation of to Label Packaging Dates for Ingle-packed Frozen Food The packaging date labeling for individual frozen desserts became mandatory.
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Food
Revision of Gum Base Labeling Regulation Food additives (coloring and preservatives) other than gum base were obligated to be indicated. Only 12 additives of gum can be indicated as gum base, and coloring and antioxidant for gum base have to be indicated separately, providing more accurate information. Improvement of Cautionary Labels Glass cooking utensils have to be divided and indicated for its use with direct fire, oven, microwave, and boiling. Any other glass utensils need to indicate that it is not to be used with fire. Improvement of Labeling Standards for Frozen Bread and Frozen Salted Fish Recently, regulation and standard for frozen bread and salted fish were partially revised. If the frozen bread and salted fish products are released to the market after defrosting, it must indicate the packaging date, thawed date, expiration date and storage methods.
04
4) Expected Effectiveness
The KFDA has been making efforts to improve the system as Customer Centered Oriented Food Labeling System. Combination Operation for Enforcement Date of Food Labeling Regulation was implemented to improve burdens and inconveniences experienced by consumers and industries
Figure 3-4-1 Expectation of Growth Rate for Health Functional Food - NBJ, 2007.
15,000 15%
0 1999 2000 2001 2002 2007 2008 2009 2010 2011 2012 2013 2014
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Therefore, it is necessary to support the consumers with better health functional food through improvement of education and promotion for the nation and professionalism of health functional food experts. The KFDA will prepare the various policies and systems to establish a great condition for production and provide quality health functional food to secure the products safety and functionality.
Size of the health functional food market: 210 billion dollar (2002) to 3,77 billion dollar (2007)
2) Advancement of Management and Evaluation for Standards and Regulations of Health Functional Food
(1) Health Functional Food Certification System
Health functional food is the product that is produced and processed with the substances that contain helpful effects for humans. Functional means that it provides nutrition control for human to improve the health. Any raw materials or substances (functional substances) with functionality are largely divided into two categories. First category substances are stipulated by Article 14.1 and 15.1 of the Health Functional Food Act, where the Commissioner of the KFDA may set standards, specification or raw materials and substances for the purpose of selling products. Second category substances are all the exceptions of the first category. These are stipulated by Article 14.1 and 15.1 of Health Functional Food Act, where information on the substances standard, specification, safety and efficacy are individually certified after data is received from the business operator, to grant a certificate. According to Article 2 of Regulation of Certification for the Material and Standard of Health, a substance that is individually certified, is functional substance for the used in health functional food manufacturing and is processed material of animal, plant or microorganism or its extract, refined material, synthetic material and compounds, Certification Procedure Article 12 and 13 of Regulation of Certification for Materials and Standards of Health Functional Food, stipulates the scope, method to document, content and requirement
But, according to the OECD healthdata 2010, Korean medical expenses per person is growing most quickly in OECD members, requiring relevant management regulations. The increased rate of medical expenses per person for U.S and Canada is 5.9%, and Korea is 11.6%. Also, the increased rate of medicine expenses of Korea is 11.3%, which is second fastest country in OECD. Figure 3-4-2 Korean Medical Expenses per Person are Growing Fastest in OECD Member
Increased rate of medical expenses per person for OECD members
annual average(%) OECD U.S. United Kingdom Spain Poland Nether lands Slovakia Korea Ireland Finland Canada Belgium Australia
0 1 2 3 4
6.7 5.9 7.2 7.7 8.1 7.0 11.5 11.6 9.9 6.1 5.9 5.7 4.3
5 6 7 8 9 10 11 12
Iceland
Danmark
of data required for submission, to receive individual certification, Required information is the following.
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Summary of the whole information Origin, details of development, condition of domestic and foreign certification and use Manufacturing method and related information Information of materials property Regulation, test method and the test result of functional substance Regulation, test method of toxic substance Information for safety Information for function Caution for the amount of intake and related information Confirming information for that substance is same or different with medicine Figure 3-4-3 Procedure of Certification and Evaluation for Functional Substance
Application Filling in an application form Processing Organization Receipt Examination Certification Notification Payment On-site investigation Consultaion
Expansion of Evaluation Organization Regulations and test results of functional and toxic substances were needed to be certified by the Korean organization, even though it is certified by a foreign organization, creating financial burdens and inconveniences for manufacturers. Therefore, it was revised so certification from foreign organizations can be used as long as it is confirmed by the Commissioner of the KFDA (KFDA notification 2010-76, October 29, 2010).
Functional Level for Health Functional Food Function of health functional food was classified to Function for reducing the incident of disease and Bioactive function. Bioactive function is classified again to 3 levels, where the levels are also divided into Helpful for ~, Might be helpful for ~ and Might be helpful for ~ but practical test is insufficient. The detailed classification is to provide the certified function information for consumers. These detailed regulations will be enforced by September 1, 2011.
items, and blood circulation (11 items), body fat (7 items), menopause (5items), regulation of blood glucose (5 items) and immune system (4 items) were next. In the recent 7 years, Garcinia cambogia extract (25 items), Conjugated linoleic acid (22 items), Milk Thistle extract (20 items) were the most certified items, and Coenzyme Q10 (19 items), Saw Palmetto fruit extract (16 items), Soybean isoflavone (14 items), Lutein compound (13 items) and Ginkgo leaf extract(12 items) were next. Table 3-4-3 Number of Functional Substances Certified
(Unit : item, The late of 2010)
2004 9 9
2005 23 4
2006 29 2
2007 36 4
2008 84 1
2009 97 1
2010 68 2
Total 346 24
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Year
3 3 3 3 3 3 3 3 3 3 3 4 4 4 5 5 6 8 13 14 13 16 19
New functional substance 25. France coast pine bark extract 26. Policosanol 27. AHCC 28. Phosphatidylserine 29. Rosehip powder 30. Guava leaf extracts 31. Plant stanol esters 32. Broccoli sprouts powder 33. Katsuobushi Oligopeptide 34. Hovenia dulcis fruit extract 35. Raffinose 36. Angelica mixed extract 37. Glucosamine 38. Casein hydrolyzate 39. Green mate extract 40. Enterococcus faecalis heating treatment powder 41. Corni extracts 42. Olive leaf extracts 43. Evening Primrose Extract 44. Coenzyme Q10 45. L-Glutamine 46. Saw Palmetto fruit extracts 47. Linseed 48. Bilberry extracts 49. Distilled pine needle concentrate 50. Soybean ferment extract 51. Creatine 52. Lutein mixed compound 53. Sardine refined fish-oil 54. Pine bark extracts mixed compound 55. Haematococcus pluvialis extract 56. Agar powder 57. Beefsteak plant mixed extract 58. Germanium yeast 59. Casein phosphopeptide 60. Albumin 61. Garcina cambogia bark extract 62. Soybean germ extract mixed compound 63. Melon extracts 64. Red ginseng concentrate 65. Sodium Hyaluronate 66. Soybean isoflavone 67. AHCC 68. Keumsa phellinus linteus mushroom 69. Amorphophallus konjac extracts 70. L-Theanine 71. DHA concentrated oil 72. Tomato extracts 73. Green tea extract 74. Zeaxanthin extracts 75. Red ginseng, Torilis japonica, corni mixed extract 76. Fructooligosaccharide 77. Saw Palmetto fruit extract mixed compound 78. L-Glutamic Acid GABA-containing powder 79. Fatty acid compound 80. Hydrolyzed guar gum 81. Polygala tenuifolia root powder extract 82. Coffee manno Oligosaccharide 83. Guava leaf extract mixed compound 84. Puer tea extracts 85. Gooseberry extract 86. Red yeast rice 87. Medium chain Fatty acids oil 88. Vegetable oil Diacylglyceride 89. Milk thistle extract 90. Hop extracts 91. Probiotics VSL#3 92. Refined squid oil 93. Nopal extract 94.Lactulose powder 95. Coleus forskohlii root extract 96. Natto yeast 97. Calcium-PGA 98. Rice bran extract 99. Lyophilized silkworm powder 100. Silver Berry extracts 101. Rhodiola Rosea extracts 102. Ginseng eleutherococcus mixed extract 103. Xylo-oligosaccharide 104. Sesame leaf extracts 105. Cranberry extracts powder 106. Nori-peptides 107. Lithospermum extracts powder 108. Salmon peptide 109. Bees wax alcohol 110. Artichoke extracts 111. Cynanchum wilfordii compound extract 112. Fermented amino acid compound 113. Ginkgo leaf extracts 114. Pomegranate extract/concentrate 115. Lemon balm extracts compound powder 116. Golden-thread Collagen enzyme decomposed peptide 117. Scholar Tree fruit extract 118. Acerola concentrates compound 119. Morus alba extract compound 120. Onion extract 121. Tienchi seng extract compound 122. Perilla frutescens extract 123. L-Carnitine tartrates 124. Green tea extract/Theanine compound 125. Rhynchosia volubilis peptide complex 126. Chlorella
2006
20
2007
16
2008
17
2009
20 22 25
30
10
15
20
25
30
2010
19
2004
2005
14
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occasionally develop them. Therefore, strong bioactive substances with potential hazards and strong pharmaco-health functional food substance that is not suitable for health and welfare, are managed. Unusable Substance for Health Functional Food was established and notified to prevent the development by the industry, securing the safety. Ephedra, yohimbine and erectile dysfunction medicines are some of them, and it is annually evaluated and added to the list. 15 more plants, including Euphorbia kansui and Tussilago farfara, were added in April, 2010, and 4 more plants, including absinth, were added in 2011, listing a total of 111 types. Recently, Regulation of Unusable substance for health functional food was integrated to Regulation and standard for health functional food.
Health functional food manufacture Sub Total vocational 337 345 356 385 401 4.2 313 319 328 349 364 4.3 Venture 24 26 28 36 37 2.8
Health functional food distributor Sub total General Distribution 46,911 47,709 55,819 60,545 70,012 15.6 45,833 46,649 54,538 59,234 68,554 15.7 1,078 1,060 1,281 1,311 1,458 11.2
Manufacturing Condition From the analysis of the production records of health functional food manufacturing, the output entered 1 trillion won market in 2010, as the first time since the introduction in 2004. It also increased 11% compared with the previous year. Among the health functional foods, the output of red ginseng product was 58,170 million won, 55% of total. Next on the list was: individually certified product (11,290 million won, 11%), vitamin and mineral product (9.910 million won, 9%), aloe product (5,840 million won, 5%) and omega-3 fatty acids product (3,480 million won, 3%). Table 3-4-6 Manufacturing Condition of Functional Food Industry (December 31, 2010)
Division 2006 2007 2008 2009 2010
10/09 (%) 1) 1$ = 1,156 won
Total output (million won) 7,008 7,235 8,031 9,598 10,671 11.2
Domestic Output (million won) 6,637 6,888 7,516 9,184 10,211 11.2 Production (ton) 10,933 10,239 12,990 19,293 48,846 153.2
Export Output (million won) 371 346 514 415 4601) 10.8 Production (ton) 667 339 697 592 367 38
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(10.12.31 now)
At the end of 2010, there are 148 GMP certified companies, 40% of 364 specialized manufacturers. Table 3-4-7 Annual Condition of GMP Certified Company
Total 148 2005 27 2066 41 2007 18 2008 15
(December 31, 2010 / unit : place)
2009 24
2010 23
Detail information of GMP certified companies is available on Health Functional Food Information Hompage (http//:hfoodi.kfda.go.kr) - GMP/GMS/Advertisement GMP
Introduction and Operation of Good Manufacturing Practice (GMP) The KFDA is operating Good Manufacturing practice (GMP) for the systematic, organized management of health functional food, to secure product safety and improve the quality. Companies can commission consignment production from the venture manufacturer for health functional food and specialized distributors, and indicate the GMP mark when it obtains the GMP certification. Vitalization Support for GMP System For GMP vitalization of small and medium companies, 14 companies received funding for GMP consulting (70% government expense, 30% own expense) in 2010.
post management including collection, examination and monitoring. Sales of illegal health functional food through the internet are creating market confusion and consumer injury. The KFDA requested the blocking of foreign illegal websites to Korea Communications Standards Commission in order to secure the healthy distribution order. The KFDA is planning to improve the collection, examination and monitoring, and keep the cooperating system with related organizations to provide better distribution order.
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Table 3-4-8 Annual Result of Deliberation for Function Labeling and Advertisement
Total Year Total 2004 2005 2006 2007 2008 2009 2,435 2,711 1,968 1,716 1,698 2,438 3,022 Result Printed media Broadcast media Number of deliber -ation 44 51 50 49 52 50 50
(Unit:item)
Appro Appro Appro Appro Inappro Appro Inappro Appro Inappro -priate -priate -priate Total Total -priate -priate -priate -priate -priate -priate in in in 444 506 518 587 452 511 699 1,813 2,068 1,420 1,073 1,180 1,768 2,123 178 137 30 56 66 159 200 2,116 2,310 1,735 1,513 1,490 2,161 2,717 430 478 490 558 438 483 665 1,566 1,745 1,227 912 1,003 1,558 1,898 120 87 18 43 49 120 154 319 401 233 203 208 277 305 14 28 28 29 14 28 34 247 323 193 161 177 210 225 58 50 12 13 17 39 46
The KFDA is operating Labeling Regulation of Health Functional Food in order to help consumers to make a right choice in their purchases. According to this regulation, only certified health functional food can use the Health Functional Food mark and labels. Recently, customers attention for sugar is increasing caused by obesity and diabetes. Therefore, the products need to indicate the sugar on carbohydrate on the nutrition label, and imported products are allowed to use Korean labeling, and revised labeling regulations were prepared to impose the product to indicate the functional level that the KFDA provides. The KFDA is planning to improve the labeling regulation to prevent customer injury and reform unnecessary controls. Pretrial of Labeling and Advertisement for Function Strict pretrial system is in progress, to prevent customer injury from false and exaggerative advertisements, and to promote fair competition and health distribution and sales. Committee of function labeling and the advertisement was constructed with food specialized organizations, customer organization, industry and experts of sitology, dietetics, medical, law and advertisement. It deliberated the 3,022 items (50 times) in 2010, which increased by 24%. It is expected to support industry development by preparing guidelines for labeling and advertising, which considers the properties of each item.
2010
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Verification of Analysis Result for Side Effect Safety Evaluation Committee for Health Functional Food was formed to verify the result of analysis for adverse effects. It is composed of 20 experts in clinic, pathology, toxic and statistics.
Subway video
April 22~May 21
Subway frame advertisement Bus frame advertisement Publicity booklet Customer education housewife, middle age, old age
April 19~June 1
Seoul line 5~8 - 600 car 4 megalopolis (Busan, Incheon, Daegu, Gwangju) Distributed at city hall, county office, gu office 60 times 4,170 persons
Providing Information on the Homepage Information of regulation, certification, report, etc is available on the homepage for health functional food (http://hfoodi.kfda.go.kr) providing the proper information for customer, inducing the healthy sales and distribution for company. Especially, information of domestic product that is certified by the KFDA and
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imported product that also reported to the KFDA is available on the health functional food - product information. Customer can check the information of product name, manufacturer (importer), license number (import report number), function, intake method, notice, regulation and standard. Figure 3-4-10 Homepage for Health Functional Food
(1) E stablishment of Technical Assistance and Infrastructure for Health Functional Food
Promoting the Autonomy Registration System for Consulting More companies are requesting the assistance of consulting institute to receive professional support on preparing the material for certification. However, some of the consultants do not have the transparency and professionalism. Therefore, imposing the company to reveal its information (commission, condition, etc.) on its own, reliable information was provided to industry. Now there are 13 consulting companies for
health functional food and their information is available on the homepage of the Korean Health Supplement Association (www.hfood.or.kr). Information of related regulations is being provided regularly. Quality of the companies is also being sustainedly improved by the professional education of the Korean Human Resource Development Institute for Health & Welfare.
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of the product and regulation for individual certification. Free job training for local developers of industry, academia and research is operating at the countries in order to improve the awareness of heath functional food.
sharply. At the end of 2010, the cultivation area covered 148 million hectares: 10% increase compared to the previous year (2009, 134 million hectares). Table 3-4-10 Annual Cultivated Area and Cultivation of Gene Recombinant
Agricultural Products
Division 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
170 1,100 2,780 3,990 4,420 5,260 5,870 6,770 8,100 9,000 10,200 11,430 12,500 13,400 14,800
Number of country
12
13
13
16
18
17
21
22
23
25
25
29
In 2010, 73 millon ha of beans, 47 million ha of corn, 21 million ha of cotton and 7 million ha of canola take most of the area, 148 million ha. There are 29 countries cultivating GM agricultural products and the top 9 are; U.S., Argentine Republic, Brazil, Canada, India, China, Paraguay and Republic of South Africa, taking up 97.% of the total area when combined. Domestic Condition of GM Agricultural Products Korea has not been commercialized in GM agricultural products. Up to now, the
2. Improvement of Safety Management for Genetically Modified Food and Novel Food
1) Outline
(1) Genetically Modified (GM) Food
GM food is agriculture, marine and livestock product that was cultivated by recombinant DNA Technique, which takes a useful gene from the organism and combines it with the gene of other organism.
Rural Development Administration has developed 150 varieties of 20 products and some of those are in the progress of commercialization including safety evaluation.
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labeling system, and separation of normal product. Therefore, importers have to choose the one that is separately produced to import non-gene recombinant agricultural products. Similarly, most of the importers are not amicable to GM products. Major international exporters have the management system for classification of non-gene recombinant products, and they impose the cost of it on the price of the product. GM beans takes 80% of the total amount of imported beans and are usually used for cooking oil. Most of non-gene recombinant beans are imported by Korea AgroFisheries Trade Corporation, and are used to make tofu and soya milk. Thus, it is difficult to find the product indicating a GM mark. Since the GM corn began to be imported in May, 2008 due to the international order imbalance, social concern became higher. The imports shrank a little by the customers refusal of GM corn since September, 2008. In 2010, 48% of GM corn were imported.
Article 9, 10
Annex
Notification
Notification 2009The designation including the 196. safety assessment object, safety Regulation assessment inspection procedure, for the safety submission of documents range, and evaluation of gene etc. recombinant food
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(2) Regulation
Regulation for gene recombinant food labeling system is like the following:
Applicant
Application form, safety evaluation material and summary
Organization via
Application
Notification
Result
Approval
Legislation of subject, time and regulation (August 30, 2000). Revision of labeling regulation according to the establishment of Regulation for Health Establishment of Regulation of GM Food Labeling Functional Food (January 31, 2004). Revision of labeling regulation according to (August 30, 2000) expansion of subject item (November 14, 2007) Establishment of deadline for reexamination according to Regulation for Instruction and Rule Management (August 24, 2009)
(3) Subject and Method for Labeling (4) Current Condition of the Safety Evaluation for GM Food
There is 71 approved GM agricultural foods (bean, corn, cotton, canola, sugar beet, potato, alfalfa, etc.), 15 food additives (enzyme) and 1 microorganism, in Korea. There are 28 approved products that contain the gene recombinant DNA and foreign protein. After production and processing, they are subject to the gene recombinant food labeling system. It does not include the products that is refined and produced without the gene recombinant DNA (syrup, soy sauce, cooking oil). Subject products have to label the GM Food for GM ~ Containing Food in a font bigger than 10 points on the front side. And if it is impossible to confirm gene recombinant substance, the product can label Potentially Containing GM Substance.
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1. Preventive and Scientific Management Infrastructure of Food Hazards 2. Securing Health by Food and Nutrition Management 3. Preparing the Organic and Systematic Safety Management from Raw Material to Consumption 4. Establishment and Operation of Food Safety Information Center 5. Reorganizing Standards and Specification for Food, Food Additives, Equipment, Container and Packaging
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05
Reorganizing Standards and Specication for Food, Food Additives, Equipment, Container and Packaging
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Legislation and revision of regulation and standard Revision of regulation for residual pesticide in agricultural products (9 kinds of pesticide including Buprofezin for chili pepper Establishment of regulation for residual pesticide in agricultural products (41 kinds including Deltamethrin) Establishment of regulation for salmonella in the cocoa products, chocolate, peanut and nut products Establishment of regulation and test method for Enterohemorrhagic E. coli in fruits and vegetables juices Materialization of sanitation regulation for process and produce of salted fish Establishment of regulation for carbon monoxide in Japanese amberjack Revision of regulation for cooking and management of restaurant food Addition of prohibited substances for food items Establishment and revision of regulation for residual pesticide
substances and expand the choice of customers. Meanwhile, it became essential to provide general information of food substances to persons in charge of food management and safety information to customers.
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3) Expected Effectiveness
By revising and expanding the food substance management system, industry was expected to be invigorated, and by expanding the advertisement and education, customers convenience is expected to be improved. Also, it can prevent the food accident, and improve the customers choice.
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Elimination of 11 substances including naphthalenesulfonic acid sodium which can be used for disinfectant Establishment of -alkyl(C6-)--hydroxypoly (oxypropylene) for usable substance Combination of 3 substances that are similar such as -alkyl (C10-C14)- -hydroxypoly(oxyethylene)poly(oxypropylene) to 1 item
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Chapter 04
Pharmaceutical Products
01 Current Status and Progress in Pharmaceutical Product Safety Management 02 Promoting Appropriate and Safe Use of Pharmaceuticals 03 Assistance in Commercialization of Pharmaceuticals 04 Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 05 International Cooperation in Pharmaceutical Sector
1. Current Status and Progress in Pharmaceutical Product Safety Management 2. Promoting Appropriate and Safe Use of Pharmaceuticals 3. Assistance in Commercialization of Pharmaceuticals 4. Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 5. International Cooperation in Pharmaceutical Sector
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Compared to the average annual growth rate (9.7%) during 2003 ~ 2008, the growth rate of domestic pharmaceuticals slowed down for last 2 years.
01
12.0 10.0
9.8 125.982
147.879
6.4
6.2
90,000 70,000 50,000 2004 2005 2006 2007 2008 2009 2010
Domestic production (100million) Growth rate compared to the previous year
2.0 0.0
The portion of domestic pharmaceuticals in Korean gross domestic product (GDP) and GDP of manufacturing industry declined slightly compared to 2009 (1.39 1.34% for GDP, 5.56 5.47% for the manufacturing industry GDP). In 2010, the domestic pharmaceutical market share (production + import - export) of the world marketplace was 19,143.7 billion won (16.56 billion dollars), which increased 5.1% (16.0% by dollars) compared to the previous year (18,220.4 billion won, 14.28 billion dollars). The domestic pharmaceutical market accounted for 1.9% of the world market (856 billion dollars) and increased by 0.2% compared to the previous year (1.7%). The market shares by region were 42.3% in North America (334.8 billion dollars), 29.2% in Europe (230.7 billion dollars), 12.4% in Asia/Africa/Australia (98.1 billion dollar), 10.8% in Japan (85.7 billion dollars) and 5.3% in South America (42 billion dollars). The world market share of domestic pharmaceuticals is still low compared to North America, Europe, China and Japan. The top domestic company in the manufacturing industry of the drug is Dong-A Pharmaceutical, followed by Daewoong Pharmaceutical, Hanmi Pharmaceutical, Green Cross, and Handok Pharmaceuticals. The production figures of Green Cross have been largely increased by the influenza vaccine for the last 2 years (455.8 billion won 562.7 billion won, 23.5% increase). The 6 largest companies occupied 25% of production, and the 20 largest companies occupied 53.2%. It was shown that large
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companies have continued to lead the market similar to the previous year (53%). The production of prescription drugs was over 11 trillion won (11,509.8 billion won, increased 8.1% compared to 10,649.4 billion won of the previous year), and the production of medicines for chronic or adult diseases, such as antiarteriosclerotic agents and antihypertensive agents, has been continuously increased. Vaccine production also increased by a double-digit percentage. The share of prescription drugs in the market has been increased by 1.2%. (72.4% in 2005 80.8% in 2009 82% in 2010) Most of newly developed drugs and incrementally modified drugs (IMD) of the nation were prescription drugs and their productions have been dramatically increased in recent years. Hence, their market share is expected to increase (new drugs: 13,150 million won (7 products) in 2004 51,250 million won (9 products) in 2010, increased by 289.7%) (IMD: 24,880 million won (2 products) in 2009 65,520 million won (6 products) in 2010, increased by 163.3%). Figure 4-1-2 Trade Statistics over the Past 7 Years
60.0 50.0 40.0 30.0 20.0 10.0 0.0 -10.0 -20.0 -30.0 -40.0 2003 2004 2005 2006 2007 2008 2009 2010
-14.7 -15.9 -19.8 -27.2 -28.7 -29.8 -26.9 -29.7 Trade Surplus/ Deficit 21.7 7.0 23.0 7.1 36.3 27.8 8.0 9.1 10.3 11.5 14.0 17.2 Export 39.0 41.3 40.9 46.9 Import
In order to overcome the productivity problem of new drug development, the new drug development, which applies high biotechnology, has been performed actively. The examples include targeted treatment solutions and gene-based therapies based on personal gene analysis, which are replacing traditional drugs and development of low molecular weight compound. The use of genetic information for targeted patient group narrows treatment targets and enables subsequent expansion of target groups. The high-tech clinical test techniques, such as micro dosing, increase the success rate of new drug development. Also, the research on biological activity and design of medicine through simulations such as diagnosis and treatment fusion through bioimaging, high-throughput screening (HTS), in silico (virtual test) and virtual screenings are also being used. The domestic new drug R&D has a considerable competitiveness. The phase 1, 2 clinical trials, which require advanced technique, is increasing every year, and 202 multinational clinical trials, 198 local clinical trials have been performed after the introduction of IND system in early 21st century.
3) Safety Management
The safety management of pharmaceuticals is being highlighted with reinforced role of regulative authorities and their globalization based on low birthrate and aging society, the increase of chronic disease, the generalization of geriatric disease, and global warming and climate changes. Due to the paradigm shift in medical services to focus on the patient focused medical treatment system and the increasing interest and requirement of detailed information on pharmaceuticals, the provision of appropriate drug information provision is essential to promote reasonable choice and use of drugs. The authority which determines policy should consider the reinforcement of surveillance, such as financial evaluations, according to the increase in medicine/medical expenses. Because of the progress of globalization by FTA and other means, the pharmaceutical industry has escaped domestic market and entered unlimited competition in the global market. Advanced countries established common pharmaceutical regulations for approval, evaluation and quality assurance through the International Conference of Harmonization (ICH) and distributed them to the global community.
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for reinforced efficiency and professionalism of approval review works through the rationalization of drug approval review fee.
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Manufacturing Practice (GMP), Good Supply Practice (GSP), for each of management phase and improved the drug quality control basis. By actively responding towards environmental changes in drug safety control, the KFDA now possesses pharmaceutical safety management capability of the global standard, including safety management of non clinical trials, clinical trials, approval & evaluation and adverse effects control. With this environment available, the KFDA should focus on enhancing its control system and contributing to international policy developments by sharing its regulation with the global community. The KFDA should also take actions in preventing or responding towards adverse effects and respond to safety incidents of wrong medicine prescriptions and preparations.
4) Establishment of Effective Recall System 1) Expansion of Customized Medical Information for Consumers
The KFDA developed and distributed the Manual on Safety Use of Pharmaceuticals at Home per drugs types, age group and disease types. It ran a project to establish Online Library of Pharmaceuticals to provide overall information, such as drug identification, warnings, and directions for use of pharmaceuticals. They also enhanced directions for use of drugs so that they are easily understood by consumers and medical specialists. The KFDA developed Web Fax, Recall Information Distribution System using SMS and Real-time Recall System for effective pharmaceutical product recall, through cooperation with Information Center of Health Insurance Review and Assessment Service. Furthermore, they tried to supplement the system by setting up recall plans, reducing recall periods and introducing recall assessment system. The KFDA conducted regulatory reforms to improve pharmaceutical policy, promoted the development of high quality pharmaceuticals, and established the basis for advanced pharmaceutical industries to enhance their competitiveness. The administration also focused on the harmonization with international regulations, such as GMP management system, and reinforced international cooperation.
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(Unit: case)
2010
02
cases
26,827 53,854
The KFDA is continuously developing statistical analysis methods to evaluate the cause and effect of domestic adverse effect reports. It also developed an efficient system to collect safety information from foreign sources by establishing contact systems with pharmaceutical companies and by searching and gathering information on-line. It allowed doctors and pharmacists to search for drug safety information faster and easier manner, and established a section on its website (http://www.kfda.go.kr) to share 'Changes in Pharmaceutical Approvals' for doctors and pharmacists to trace any changes in approval requirements. The KFDA directed 264 safety measures in 2008, such as limiting the approval for diazinone, and 283 in 2009, such as modifying approval content of gabapentin. In 2010, the KFDA directed 144 safety measures, such as prohibiting the use of sibutramine or modifying approval content of another 115 drugs.
1. Active Reporting of Adverse Effects and Scientific Assessment of Pharmaceutical Safety Information
The KFDA revised the Regulation to Manage Safety Information of Pharmaceutical Products in 2004 and 2005 to specify reporting period, assessment procedures and standards, and distribution method. In 2007, it became mandatory for pharmaceutical companies to hire an employee in charge of post-market management through adverse effects monitoring or any other methods. In 2008, the KFDA requested pharmaceutical manufacturers and importers to report safety information on an annual basis and made reasonable improvements in risk events that required an immediate reporting. Lastly, it enforced relevant businesses to prepare Drug Surveillance Standard Manual. The KFDA also operates regional drug monitoring centres for active drug monitoring. The centres collect adverse effects information of the region, reward participating institutions or reports and train doctors and pharmacists in an adverse effect monitoring. There were 6 regional drug monitoring centres in 2006, and now 15 centres are active (2010). It is to expand to 20 centres by 2011 to reinforce information collection capacity. The number of domestic reports on adverse effects of drugs continuously increased, showing 1,841 cases in 2005, 2,467 cases in 2006, 3,750 cases in 2007, 7,210 cases in 2008, 26,827 cases in 2009, and 53,854 cases in 2010.
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improper use of drugs through assessment on the appropriate use of drug since 2001. However, there were limitations because there is no system available to distribute the information to the public or assess the information. The Ministry of Health and Welfare began to provide information on appropriate use of drugs that were prohibited from mixing and had age limits in 2004 and that became the start of information provision in the appropriate use of drugs. In September 2005, the responsibility to develop and distribute such information was given to the KFDA, which was specializing in the assessment of safety and efficacy of drugs. The Ministry of Health and Welfare and the Health Insurance Review & Assessment Service took the role to manage and inspect that pharmaceuticals were being used in appropriate manners. After the transfer of responsibility, the KFDA has been adding the list of drugs that possess higher risks, are prohibited from joint use, have age limits and are prohibited for use by pregnant women, to supplement current information on the appropriate use of drugs. As of 2010, the KFDA is providing and controlling 473 ingredient combinations of medicines prohibited from joint use, 108 medicines prohibited from use in a certain age, and 314 medicines prohibited from the use by pregnant women. In 2010, the KFDA developed and distributed a 'Booklet of information on appropriate use of drugs for pregnant women' for pregnant women and non-specialists the field of gynecology. The KFDA is also preparing to publish similar booklets for children, patients with nephritis and epileptics in 2011. Likewise, it is determined to lead safe and proper prescription and preparation of medicine through the development and distribution of information on treatment dosage, time period, and duplicated drugs to improve public health.
The KFDA established and operated private-public consultation composed of the Korea Consumer Agency, Consumer's Korea, the Korean Pharmaceutical Association, the Korean Society of Health-System Pharmacists and 10 other related specialists recommended by pharmaceutical communities. The group prepared methods to support the distribution of non tar coloring cold medicine for children in Jul 2009, to ease the anxiety of consumers on tar colorings. As detailed support plans, 'dye-free' label was allowed to be displayed on the external container and package to make it distinguishable, and efficiently processed approvals for tar coloring free syrups by designating them as 'priority evaluation target' for 1 year from July 1, 2009. The KFDA established the distribution plan of dye-free products to expand the right of choice of consumers although it recognizes that coloring may prevent from their misuses. Moreover, targets drugs that require safety container/package to prevent safety accidents caused by improper drug use in children are being expanded. The safety container and package of drugs were introduced to prevent drug safety accident, such as overdosing by easy unlocking, and careless handling and storage of drugs at home. In the previous regulation, only 5 substances, including product containing iron over 30 mg, had to use child-proof container/package. Since the revision of the Pharmaceutical Affairs Act of June 19, 2009, the drugs containing loperamide (used in diarrhea medicine), naproxen and ketoprofen (anti-inflammatory analgesic drug), should use this container/package. There drug labels are often wordy and unclear, causing consumers misunderstand important information while the demands on medical supply safety information of consumers are growing fast. The clarity of the markings on drugs was also low for some consumers. The KFDA established a working group with the specialists
recommended by medical communities, pharmaceutical communities and consumer communities, such as the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical Manufacturers Association, the Korean Research-based Pharmaceutical Industry Association, the Korea Consumer Agency and Consumers Korea. The working group is trying to enforce the manufacturers to change labels on drugs for easier recognition, both visually and intellectually. The KFDA tried to satisfy consumer's right to information by researching basic terms related to important facts on drugs and labeling by reviewing 736 simple terms in 2009
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and 66 simple terms in 2010. The administration combined the Guideline for Labeling of Pharmaceutical Products and Rules on Tablet Imprint Identifier to establish a Regulation on Pharmaceutical Product Labeling, improving the publics understanding on pharmaceutical labels. According to the regulation, medicines that require the use of the general term must display the term them beside the professional term. (i.e. "Expectoration (phlegm)" or "bite (injury through biting)"). The font size should be over 6~7 point according to the Korea Industrial Standard, and only key information should be written on the outer package. On the container or package, product name, expiration date, the name, standard and quantity of active ingredients, and identification for "prescription drug", "over-the-counter drug" and "drugs with potential abuse and misuse" should be displayed with font size 7+, while the other information should be written in font size over 6 point. The attached leaflet in the package should use the font size 7+ if it is over-the-counter drugs and 6+ for prescription drugs while spacing between the lines should be 0.5+. The important warnings for drug found in its approval information should be written in letter box, and others should use appropriate fonts such as bold letters, shades, colors and letter boxes for easy distinction. Since secondary packages for drug information leaflet is often lost, the address of online KFDA medicine information forum or company website should be written on the container and package to allow consumers to search for further information.
dispensing of drugs, the development of information technology including the internet and advance in transportation technology such as parcel service or airmail, have not only diversified the distribution route of illegal or defective drugs but also torn down the border lines between countries existing to prevent the illegal distribution or spread of happy or illicit or counterfeit drugs with potential abuse and misuse. The KFDA and local government performed frequent pharmacovigilance on illegal or defective drugs based on reporting and information to find illegal traders. The administration also tried to block or eliminate manufacturing sites used to provide illegal sales of drugs. A MoU was also signed with the Korean Internet Corporation Association for cyber monitoring of illicit drug distribution. Table 4-2-2 Blocking and Elimination of Request for Illegal Sales of Drugs
(Unit : case)
2007 394
2008 168
2009 449
2010 822
The KFDA is working with Criminal Investigations Office and the National Police Agency to build an efficient monitoring system on the illegal distribution of drugs. This includes the surveillance on the distribution of illegal/defective drugs and the blockage of the domestic inflow of illegal/defective drugs, by utilizing imports information network of the Korean Customs Service.
The KFDA will optimize the jurisdiction in illegal drug investigations and lead voluntary shutdown of illegal sales site of drugs. It will also emphasize that drugs being sold online are illegal or defective, highlight the illegality of online drug sales and danger of purchase online and inform the limitation of consumer's right according to Consumer Act when purchasing drugs through the internet. The KFDA will attend workshops, conferences, meetings hosted by International Medical Products Anti-Counterfeiting Task Force (IMPACT) of WHO to cooperate in the prevention of global distribution and spread of illegal or defective drugs including imitation drugs.
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medium and drugs in 2008, 1,747 products including herbal medicines in 2009, and 1,365 products including medicines for the central nervous system in 2010. The bioequivalence re-evaluation examines the statistical equality of the coefficient of utilization in the living body between approved generic medicines and standard medicines (reference products). It is performed by receiving bioequivalence test plans and reporting the test results. The bioequivalence re-evaluation has been performed since 2007. The KFDA completed re-evaluations of 22 ingredients including gliclazide and 883 products in 2007, 14 ingredients including gabapentin and 381 products in 2008, 62 ingredients including nabumeton and 552 products in 2009, and 14 ingredients including nimesulide and 23 products in 2010.
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applicable to Standardized Manufacturing Process, which includes over-the-counter (OTC) drugs, cut down GMP review period from 120 to 90 days, cut down processing period to 60 days if a product in the same dosage form was being produced in the
03
same manufacturing facility (onsite inspection exempted, sterilized products are not applicable). The KFDA allowed simultaneous validations of already approved products, lightening the burden of manufacturers. The products under Standardized Manufacturing Process were expanded to reduce costs and exempted GMP data submission for export only products, and reinforced facility standard for cephalosporin antibiotics and cytotoxic anticancer drugs to separate their manufacturing facilities. Furthermore, the administration expanded Onsite Training of Pharmaceutical Manufacturers to train on writing up validation protocols and reports. Seminars and working-level training on test method, cleaning, utilities (HVAC system, water system) and computer system validation which have been compulsory since January 2010 were held and 1 : 1 consultation became available to support the industry. In order to save expenses in drug manufacturing, import and approval, the sample for 1 test was received if for items that have no influence on testing environments based on sample amounts. Although drugs, which have been imported for the first time, must pass the examination of Research Institutes of Public Health & Environment in a city or province, there were complaints in terms of redundancy due to GMP on-site inspection for manufacturers and routine inspection for drug importers. Presently, as for the imported drugs which fall within the scope of pre-approval GMP inspection, on-site GMP inspection on overall manufacturing-quality management of foreign manufacturers can be performed instead of the pre-marketing examination. There are some problems among patients who relied on psychotropic drugs for treatment as they were not allowed to be carried during overseas trips. Also, demands for the immediate authorization through additional designation of orphan drug to supply them on time and decrease the cost spent by patients suffering from rare diseases. The KFDA designated 6 additional ingredients including citric acid and caffeine, and added infant apnea medicine as new orphan drugs in 2010 to expand treatment opportunities. The KFDA launched serviced researches on the solutions of the safety problem of marketed medicinal products and disposal of unused drugs. As a result, the agreement on the introduction of small quantity packaged drugs was drawn among related organizations such as Pharmaceutical Association and Pharmaceutical
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Manufacturers Association based on the agreement, 'Regulations on Small Quantity Packaged Drug Supply (KFDA notification)'. According to the regulations, over 10% of total annual output of tablets/capsules must be supplied with a small quantity package. The KFDA established Information System on Supply and Demand of Small Quantity Packaged Medicine to prepare the basis of self management of small quantity packaged medicine supply by pharmaceutical manufacturers and Pharmaceutical Association in March 2010. The KFDA also established and operated working-level consultation groups with the Korea Pharmaceutical Association, Korea Pharmaceutical Manufacturers Association and Korea Pharmaceutical Import-Export Association to consult on the contents of the system, operations, and public relations measures, and enhancement measures. The KFDA applied differential supply standards of small quantity packaged medicine to be below 10%, for 175 items, as requested by the pharmaceutical manufacturers. This was approved by the Korea Pharmaceutical Association to decrease stock expenses on small quantity package of low demand products.
and the number of products which were approved with comparative clinical trial was 1. The number of approved drug substances including DMF, human placenta medicine, and additionally designated drug substances were 123 (Guideline on Registration of Drug Substances). The number of DMF declared drug substances were 1,198, and the number of DMF declared new drug substances was 60. 146 products of additionally designated drug substances were declared (including canceled products). The KFDA established the Plan to Reformation DMF System' as a general reformation of the management system on drug substances in 2010 to improve duplicated evaluation and range of submitted data used in DMF registration and drug substances approval (registration), and perform on-site inspection based on 'Guidelines on Pre-Approval GMP inspection for Drug Substances' through the abolition of conditional DMF notification.
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equivalence test to protect test subjects according to Good Clinical Practice (GCP), and to secure reliability of test analysis according to GLP. When the biological equivalence test is needed to acquire approval of generic drugs, the test plan should be approved by KFDA. In 2010, 388 biological equivalence test plans were approved. When classified by active substance, the ingredient most frequently certified by the biological equivalence test plan was glymephiride-metformin hydrochloride complex (57 approvals). The number of approvals on olmesartan medocsomil-hydrochlorotiazide complex, the high blood pressure medicine, was 46, and the number of pitavastatin calcium, hyperlipemia medicine, was 34. Biological equivalence tests for these products have been completed in 2011, and applications for approval are expected to be submitted soon. In terms of drug function, circulatory system drugs, including high blood pressure medicine, hyperlipemia drugs and antiarteriosclerotic agents, gained 150 approvals (38.7%). It can be analyzed that Korea is entering an aging society and the development of the circulatory system related drugs is increasing accordingly.
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in 2010 are 'Guidelines on the preparation of approval application for anticancer drugs', 'Guidelines for the assessment of on-site inspection on biological equivalence test', 'Guidelines for preparation of review application data' and 'Guidelines for preview processes on drugs.'
current status of approval and approval on biological equivalence test plan, internal guidelines, approval and evaluation result, were provided to enhance consistency and transparency of evaluation tasks and increase the predictable administrative services.
(2) T he Enactment and Revision of Evaluation Regulation and Development of Assessment Guideline
The domestic medicine evaluation regulations should be enacted or revised consistently with the consideration of the latest scientific development and international regulation from ICH. However, such regulations are not detailed or clarified, causing the KFDA define them through consistent regulation revisions. The KFDA enhanced mutual understanding between reviewers and applicants and provided faster processing of civil inquiries by explaining relevant authorities assessment methods. The KFDA released 'Internal KFDA Guideline on Approval and Review to the public in July 2006, and established 'Guidelines on the Application of Drug Approval' by summarizing regulations on approval applications, target products and necessary review factors, to prepare pharmaceutical companies. As for clinical trials, the KFDA enacted or revised a total of 6 clinical trial assessment guidelines for each disease. The guideline included explanations on planning, performing and assessing of clinical trials. It also provided factors to consider in drug development, in terms of standard selection, possible exemptions, safety and efficacy assessment variables to decrease drug development related expenses and time allocated to pharmaceutical manufacturers to perform clinical trials.
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1997, assessment systems for 6 dosage forms were introduced to simplify the KGMP. Since the designation of GMP, as compulsory requirement for finished products in 1994 and for drug ingredients in 2002, the quality of medicine has been largely
04
improved. However, GMP was designated only for 7 major dosage forms, therefore, needed to be narrowed down. Although medically advanced countries carried out validations, a key factor in GMP, but it had not been introduced to Korea. For this reason, the revision of GMP standard was required. As a reference, U.S. introduced GMP in 1963, validation in 1987 and its management procedures in 1995. Japan also introduced validation in 1995. Since Korean GMP standard was not harmonized with the international standard, complications were experienced in signing MRA with other countries and in exporting pharmaceuticals. Also, deviations of quality among domestic companies also occurred. The production scale of domestic pharmaceutical industry is ranked 11th in the world, but the majorities were small companies and lacked large scale company with international competitiveness. Meanwhile, multinational companies grew bigger through M&A. The average production scale of domestic companies is only 50 billion won in 2008 and the ratio of ordinary profit is extremely low. It means that domestic pharmaceutical manufacturing companies preferred to manufacture generic medicines than new drugs as they require a larger scale of long time investment. In this condition, the KFDA introduced new GMP system to confirm the quality from raw materials to finished products and establish competitiveness compared to advanced foreign pharmaceutical manufacturing companies. The KFDA chose research projects to improve KGMP and prepared a draft in 2003 to harmonize with GMP of international organization or advanced countries. The KFDA composed KGMP revision research team and ardently reviewed since early 2004 and revised KGMP as Annex 2 of Enforcement Regulation of Pharmaceutical Affairs Act in January 15, 2008.
2) Background
The WHO announced GMP standards during the 22nd WHO general assembly and recommended the implementation of GMP system to its member countries in 1969. Korea notified the GMP standard as Ministry of Health and Social Affairs Regulation no. 373 in the name of Good Manufacturing Practice in March 1977 and participated verification system on GMP implementation in June 28, 1969. Since then, the KGMP was stipulated as 'Good Manufacturing Practice in Annex 4 of the Article 22 of Enforcement Regulation of Pharmaceutical Affairs Act in July 1994, and as an approval requirement in manufacturing business and product items. In
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WHO. The amended was introduced in a phased manner. The pre-GMP assessment changed its orientation from dosage forms to product types and was initially applied to new and prescription drugs. Later on, manufacturing validation was applied, corresponding to item-orientation. This was to support industries in accepting changes in the regulation. In 2010, validations for cleaning, analytical method validation, utility system, and computer system were fully implemented. Now Korea completed the introduction of GMP system that is in level with other advanced countries.
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passed the inspections. It shows that the adaptability of domestic pharmaceutical industry to validation processes has been improved, and new GMP system is well implemented without many complications.
products including dextrin. The Supplement 3 was published as a KFDA notification 2010-27 (May 3, 2010). The KFDA added purity tests in recorded products to establish reasonable management system and revised to meet latest scientific advances and international trends. The previous revision was published in 2009 to correct some imperfections on operational
conditions. The main revisions of this supplement are the establishment or the reinforcement of purity test on heavy metals and microbiological criteria for 95 products, including thyroid sicca, rotation test for diltiazem hydrochloride and amikacin sulphate, addition of limit standard and inclusion of test method on coumarin in the definition and quantitative method of cinnamon oil. The purity test of ethambutol hydrochloride and identification test of pravastatin sodium were removed, and the range of target microbial strains for sterility test, criteria test, preservation test, final sterilization and sterilization index in general tests were expanded. Also, 'powder X ray diffraction method' was added to the general test method.
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Table 3-4-6 Current Statistics of Products Included in Drug Standards of Korean Pharmacopoeia
Type number of products NonHerbal prescription medicine medicine 1,440 574 Radiopharmaceutical 43 External diagnosis medicine 36 Drug additives 15 total 2,108
were inappropriate and removed from the list, and 11 colorings for external use were limited to quasi drug only. The mixture limit of tar colors was decided to be set below 0.1%, considering medicine manufacturing guideline of Japan. If tar colors are used over 0.1%, a separate review is required.
3) D esignation, Standard and Testing Method of Tar Color for Pharmaceuticals, Quasi-drugs and Cosmetics
The Designation, Standard and Testing Method of Tar Color for Pharmaceuticals, Quasi-drugs and Cosmetics was established by the Minister of Health and Social Affairs Notification No. 87-42 to classify tar colors for use in drugs, quasi-drugs and cosmetics and establish their standards and test methods. It has been continuously updated to secure the quality and adapt to international trends. The standard and specification of EU, U.S. and Japan was investigated in 2008~2009 and the revision was published based on the investigation. It became KFDA notification no. 2010-32 (May 14, 2010). It established purity test for mercury, heavy metals, zinc and iron in 42 tar colors including red 3 from Table 4, changed mercury and other 4 test from Table 5, and developed a method to conduct acetate ammonium solution test for 15 products including red 2 (amaranth). Also, Table 2 and 3 were partly amended. Meanwhile, the general audit of health and welfare committee in the National Assembly pointed out safety concerns on tar colors for medicine, including iron products distributed for free from health centers to pregnant women, and consumer organizations and media also pointed out safety concerns of tar colors. Hence, relevant divisions of KFDA discussed control method of tar colors. Among the 76 tar colors authorized for use in drugs and quasi drug, some are not used advanced countries for safety reason and some, such as tar color mixture ratio, are lacking dosage standards. Thus, the removal of inappropriate colors was discussed to refine the relevant standards. Korea Pharmaceutical Association and Korea Pharmaceutical Traders Association investigated tar colors by checking their usage and referring to standards of U.S. and EU. The review showed that 17 tar colors
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1. Current Status and Progress in Pharmaceutical Product Safety Management 2. Promoting Appropriate and Safe Use of Pharmaceuticals 3. Assistance in Commercialization of Pharmaceuticals 4. Establishment of Foundation for Supply of Safe and Effective Pharmaceuticals 5. International Cooperation in Pharmaceutical Sector
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international cooperation is becoming crucial to handle international medical safety problems, such as the spread of H1N1 virus and heparin pollution.
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2) International Cooperation
(1) I nternational Conference on Harmonization Global Cooperation Group (ICH-GCG)
The ICH was established by U.S. (Food and Drug Administration), Japan (Ministry of Health, Labor and Welfare) and EU (European Medicines Agency), the leading countries of new drug development and pharmaceutical industries (EFPIA, JPMA, and PhRMA). The ICH is a committee that has been developing international standards by the publication of ICH guideline for the past 18 years. The observers of ICH are WHO,
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European Free Trade Association (EFTA) and Health Canada. They have a role as a link between ICH members and non-ICH members. Korea is involved in ICH-GCG from ICH tasks. The ICH-Global Cooperation Group (ICH-GCG) is a subcommittee of the ICH Steering Committee and established in March 1999 to involve other interested parties. The ICH-GCG is an organization composed by ICH associated countries, ICH secretariat and associated countries of Regional Harmonization Initiatives (RHI), Drug Regulatory Authorities (DRAs)/Department of Health (DOH). Around 30 people participate in the assemblies every 2 years. Korea has been also participating in the ICH Regulators Forum established in November 2008, composed of regulation authorities of ICH-GCG associated countries. Its aim is to help countries without ICH membership on the application of ICH guidelines and share and discuss issues experienced by regulatory authorities. This forum is an organization composed by the Regional Harmonization Initiatives (RHI), Drug Regulatory Authorities (DRAs)/ Department of Health (DoH) members among ICH associated countries. Around 15 people participate in the assembly every 2 years. Korea has been gathering information on international conditions of ICH Q7 (GMP), ICH E6 (GCP) and GRP, and newly participating authorities are Brazil and China and member countries. In 2009 (October 28-29, 2009), Korea participated in the ICH Steering Committee assembly to discuss the safety assessment on anticancer drugs laboratory safety assessment of biopharmaceuticals development and manufacturing of drug substances clinical assessment of antiarrhythmic drugs gene-therapeutic drugs and assessment of Pharmacopoeia. The ICH Steering Committee is composed by ICH associated countries (the governments of U.S., Japan, EU) and pharmaceutical industries (EFPIA, JPMA, PhRMA). The committee grants 2 representatives of each country and pharmaceutical industries (total 12) to the committee meetings. There also is the ICH secretariat and WHO, EFTA, Canada (Health Canada) as observers. The main Steering Committee discusses and approves every ICH activities. In 2010, the KFDA is inviting a specialist from ICH associated countries such as U.S. (FDA), Japan (Welfare Ministry) and EU (EMA) to become a member for the KFDAs the advisory committee on drug adverse effects. Korea is to participate in expert working groups (Environment Working Group and International Working Group) as a member of ICH-GCG.
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2010. In this meeting, 3 countries shared the progress since the assembly of the Korea-China-Japan ministers of health care in 2007. The meeting also established a base article on operation of scientific research among working groups. For the Research on Ethnic Factors, Korea-China-Japan established a concept paper to described detail and plan of the research. The research group is a scientific discussion group that offers opinions to the working group and is composed by a maximum of 6 members from regulation authorities. The PR and liaison officials are assigned among the members. For the information exchange for the scope of clinical trials, Korea will prepare a comparative table of clinical trials system layout with the cooperation of each country and compose a concept paper on the basis of the table. They agreed that the establishment of MCRT guideline by research group (China), the regulation harmonization on joint GCP inspection (Korea) will be discussed in future meetings.
Committee and organization and launching of Korea-China Drug Approval and Evaluator Committee.
(3) K orea-China MOU and Operation of Working-Level Consultative Group in the Drug Area
This consultative group was organized by The cooperation contract on food, drugs, cosmetics and medical devices between the KFDA and the department of national food and drug control of the People's Republic of China in April 2009. According to this contract, the working group has been organized for each of the specialized area and support tasks of higher level consultative groups. The principle of the installation of working level consultative groups is 4, looking into a scope for drugs (including herbal medicine), cosmetic, medical devices. However, higher level consultative groups can change the organization. According to the decision of higher level consultative groups, the working group meeting will be hosted every year and the representatives of the groups are director generals of each organization. If it is needed for operational conditions, the consultative groups can invite private experts or related person of import/export companies. For the efficient operation of the consultative group, Korea and China can designate a liaison officer of their own. The second Korea-China senior conference and medical working level consultative group was hosted in Seoul, July 26, 2010. In this meeting, both countries agreed to the mutual launching of Korea-China Approval and Evaluation Symposium for Pharmaceuticals, the continued operation of Korea-China Drug Quality Standards
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Chapter 05
1. Conditions and Prospects of Biopharmaceutical Products Administration 2. System Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
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01
1) Outline
Bio-Industry, which directly utilizes the biotechnology including DNA, protein, cells for production and service has been evaluated as the new industry that will take the lead of 21st industrial growth in the fields of medicine, chemistry, environment, food, energy, agriculture and marine. It is most actively applied in medical biotechnology (Red Biotechnology, Red BT), although its value is being heavily considered in both agricultural biotechnology (Green BT) and industrial biotechnology (White BT), as well. To overcome the limitations of existing new synthetic drugs, the multinational pharmaceutical companies which focus on synthetic chemical medicines like Pfizer and Merck, are actively entering into the field of bio medicine through the M&A and alliance. The Korean government is also making an effort to set a budget for supporting the development of new biopharmaceutical products of high values by establishing relevant guidelines.
After the establishment of Biotechnology Support Act in 1983, Korea began the promotion of methodical researches and developments of bio-technology, and built the mechanical infrastructure according to the first Basic Plan for Biotechnology Support (1994~2006). From 2007 to the next 10 years, Korea is also planning to promote essential tasks on each of the 8 relevant ministries for the industrialization of advanced medicines. The second Basic Plan for Biotechnology Support (2007~2016) is aiming place Korea within the top 7 countries with expertise in Biotechnology.
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11% 89%
28% 72%
50% 50%
Koreas rank in publishing scientific papers (SCIE standard) Koreas ranks in possessing experts (USA patents standard)
Basic plan to promote brain research support (1998)
The leader of advanced biopharmaceutical products is Recombined Medicines, which are produced by the gene recombination technology. It currently takes up 10% of the worlds pharmaceutical market since its introduction in 1982. After the birth of Dolly the sheep at Roslin Institute in1997 and the completion of Human Genome Project by the U.S. in 2000, gene therapy and cell therapy products are in the spotlight as the second leader of biopharmaceutical products. vanced biopharmaceutical products have shown a great growth through the cardiovascular medicines, such as EPO (erythropoietin) and TPA (tissue plasminogen activator), and cancer medicines, such as CSF (colony stimulating factor), interferon and interleukin. More products are being developed to treat immunological and respiratory diseases, and research on incurable diseases is also in progress. As the patent of the first generation advanced medicines, such as insulin and human growth hormone products, are about to expire, the biosimilar market is expected to formed in US and Europe. The patents of gene recombined protein drugs that were released in the late 1980s have or will expire in the next few years. Table 5-1-3 Patent Expiration of Major Advanced Pharmaceutical Products
No Name of the product Enbrel Epogen Remicade Avonex Rebif Humalog Neupogen Ingredient Company Symptom Market breadth* Expiration year (a number in of the patent the thousand (U.S.A. patent) million dollor) 5.0 5.3 4.4 1.8 1.6 1.4 1.2 2012 2013 2013 2013 2013 2013 2013
First basic plan for biotechnology support (1994) 22nd 29th 21st
15th
17th
~16
1 2
Etanercept Epoetin alfa Infliximab The interferon beta-1a The interferon beta-1a Insulilispro Filgrastim
Amgen Amgen Johnson & Johnson The biogen Idec Serono Lilly Amgen
Rheumatoid arthritis Anemia Rheumatoid arthritis Multiple sclerosis Multiple sclerosis Diabetes Neutropenia
Sales by Technology($bn) Biotechnology Conventional Other Unclassified Sales Total Rx & OTC Sales % of total Rx & OTC sales Biotechnology Conventional/Unclassified
Analysis of Sales by Technology 2010 2008 28 108 222 408 60 127 310 643 9% 91% 17% 83%
3 4 5 6 7
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No
Ingredient
Company
Symptom
Market breadth* Expiration year (a number in of the patent the thousand (U.S.A. patent) million dollor) 1.1 1.6 4.5 2013 2014 2015
the clinic tests for dendritic cells, activated lymphocyte and cord blood stem cell. Table 5-1-4 Current Status on the Approval for Advanced Biopharmaceutical Products
Divition Cell Theraphy Products DNA Chip Genetically recombinant medicine Total 11 6 199 2001 1 0 12 2002 1 0 27 2003 0 0 31 2004 0 2 13 2005 1 0 16 2006 1 1 13 2007 6 2 30 2008 0 0 35 2009 1 1 22 2010 4 1 5
8 9 10
Gaucher disease Multiple sclerosis Non-Hodgkins lymphoma The leukocyte promoting improvement Diabetes Rheumatoid arthritis Breast cancer Colorectal cancer Macular degeneration
11 12 13 14 15 16
According to the Korea Institute for Industrial Economics and Trade (KIET), domestic advanced biopharmaceutical products are expected to have an annual average growth of 19%, based on production rates, and form a 13.9 billion valued market, which is higher than the estimated average growth rate for the world.
Gene therapy products, which insert the genetic material into the body, are being studied for the purpose of curing genetic diseases although is only in the clinical trial test period. Recently, China permitted Gendicine, the medicine for head and neck cancer, in 2004. The value of the genetic therapy market was 350 million in 2005 and is expected to grow to 59.19% between 2005~2010. In 2010~2015, it will reach 29.9%, market size being estimate to be 13.4 billion dollars. (Reference: Biotech Information Potal, July, 2007)
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terrorism, while Dong-A Pharmaceuticals is establishing a consortium with Daewoong, Genexine, and Pohang University of Science and Technology for the commercialization of HepB DNA vaccines and is conducting clinical trials on AIDS DNA vaccines in cooperation with Genexine. Table 5-1-5 Current List of Clinical Trials for Major Vaccines and Plasma Derivatives
Company Product GC1102 Green Cross MG1109 Green Cross GC1109 Green Cross GC1107 MSD-Korea Sanofi Pasteur Korea Dong-A V710 Inj Pentaxim Inj HB-110 Dong-A GX-12 Ingredient Recombined HepB immunoglobulin Avian influenza vaccine Recombined Anthrax vaccine (Absorptive) Td vaccine for adult Staphylococcus aureus vaccine DTaP-IPV-Hib combined vaccine HBV antigen gene expression Plasmids HBV antigen gene expression Plasmids Note HepB Prevention of Avian influenza Prevention of Anthrax Prevention of Tetanus and Diphtheriae Prevention of Staphylococcus aureus infection Combined vaccine DNA vaccine to treat HBV patients Treatment for HIV pateints
Green Cross
Green Cross
Dong-A
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Development and Sales Sales of Influenza vaccine, Japanese encephalitis vaccine, Hib vaccine, Typhoid fever vaccine and etc. Development of Td vaccine for adult Sales of Influenza vaccine, Smallpox vaccine and etc. Sales of HepB vaccine, Influenza vaccine, Japanese encephalitis vaccine, Typhoid fever, DTaP vaccine and Hib vaccine Sales of Influenza vaccine, DTaP vaccine, Typhoid vaccine, Polio vaccine, HepB vaccine and etc. Development of Anthrax vaccine
1. C onditions and Prospects of Biopharmaceutical Products Administration 2. S ystem Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
02
1. Outline
Biological products like vaccines are being frequently used in social classes that exhibit vulnerable dispositions, such as children. Since biological products safety and efficacy are immeasurable by physical and chemical testing as they are manufactured from materials deriving from living organisms, their quality management is much more difficult than general medicines produced from chemicals. Therefore, the steady management of quality is necessary. The Korea Food and Drug Administration (KFDA) is planning to improve the current system of national testing for biological products that are distributed domestically by applying lot release testing system of advanced countries, which focuses on the finished product. This is to strengthen the quality assurance system for and promote safe distribution of biological products. The KFDA requested for the revision of the Enforcement Regulation of Pharmaceutical Affairs Law, to unify standards for imported plasma and set legal basis for Plasma Master File System and look-back procedures. The administration is also establishing regulations for Plasma production, quality management and reporting, as a preparation for an upcoming revision of the above law. The KFDA is also establishing a safety management system for biopharmaceutical products that derive from human and animals being developed in large quantities.
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tests on imported plasma products and amended the relevant management standard for regular inspection of the exporting companies. The KFDA is also running a testoperation of Plasma Master File (PMF) System with the Korea National Red Cross. The PMF system enables the documentation of manufacturing and storing processes of plasma derivatives from the initial stage of blood donations. Last year, mandatory application of PMF system was extended to imported plasma. Currently, the revision of the Pharmaceutical Affairs Law is underway to combine separate standards of domestic and imported plasma products. The pharmaceuticals derived from human placenta is not currently considered as biological products. However, they are being managed as biological products by the Biopharmaceuticals and Herbal Medcine Bureau of KFDA since Nov 23rd, 2005, as they were deemed necessary to be applied with an appropriate level of management.
3. Establishment of the Safety Management System for Plasma Derivatives and Pharmaceuticals Derived from Human Placenta
The first requirement to consider in securing the safety of plasma derivatives is the system to provide raw materials that are not infected with pathogens such as virus. For that, the KFDA made it an obligation to conduct polymerase chain reaction (PCR)
sale/import approvals additional to the confirmation of quality, non-clinical and clinical equivalency with its innovator product.
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projects were to revise current approval and evaluation system through regulatory improvements and policy reforms.
03
1. Outline
increasing.
Fostering the Biopharmaceutical Products and Building the Foundation of Support System
1) Improvement of the Assessment System for Advanced Biopharmaceutical Products that Utilizes New Technologies
The necessity of the assessment guideline to evaluate the safety and efficacy of biopharmaceuticals according to its characteristics has been continually propounded. Hence, the KFDA published a total of 85 guidelines; 18 in 2005, 14 in 2006, 14 in 2007, 20 in 2008, 8 in 2009 and 11 in 2010, contributing to the development of advanced biopharmaceutical products. Since 2008, the KFDA opened the Guidelines information center for the biopharmaceutical products section on its home page, offering the easy retrieval of existing data. Also, the administration enabled the public to suggest guidelines or submit opinions to strengthen two-way communication, while disclosing the progress of the guideline development for transparency and objectivity. After publishing 85 guidelines from 2005 to 2010, it is now planning to publish another 7 guidelines in 2011 to support the development of new products.
Recently, bio-industry was selected as a growth engine industry for the next generation. Therefore, demands that KFDAs mission should be expanded not only to the safety management but also to policy development for industry support, is Consequently, the Biopharmaceuticals and Herbal Medicine Bureau is converting its management style as a regulator to a customer-focused management practice for the productization of advanced biopharmaceuticals. It will also expand current policies to provide wider supports for R&D of new drug products.
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3) P reparing the Approval and Evaluation Standards According to Characteristics of Cell Therapy Products
Due to medical trend shifting towards customized treatment, the importance of the cell therapy products is being magnified. According to the Item Approval and Evaluation Regulation for Biological Products (KFDA notification), a cell therapy product is considered as a medicine manufactured by in vitro manipulation of the living, autologous, allogenic and xenogenic cells through physical and chemical methods such as culture and propagation. Cell therapy products are defined as autologous or allogenic or xenogenic by cell origin of the cell, or, tissue cell therapy or immunocyte therapy or stem cell therapy by cell type. By the end of 2011, cell therapy products licensed by KFDA will be 16 items, and in July 2011, the worlds first stem cell therapy product received an approval. There a total of 61 cases of approved clinical trials and 22 cases of these are tests for stem cell therapy products. Majorities of cell therapy products are expected to be released soon. The KFDA is doing its best to lead the international field of cell therapy, by improving approval and evaluation standards for cell therapy products and suggesting relevant guidelines of international standards.
1. C onditions and Prospects of Biopharmaceutical Products Administration 2. S ystem Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
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1. Outline
Human tissues for transplantation are part of the human body such as bones, cartilage, ligaments, tendons, skin, blood vessels, heart valves, amniotic membrane, fascia and etc., given to donated by brain-dead patients or the deceased or survivors. Unlike the organs (liver, kidney and etc.), human tissue is less likely to be rejected by the host, is available for long-term storage (3 to 5 years), and can be given to multiple patients by a single donor. However, if the donor has an infectious disease like HIV (AIDS), HepB, HepC and syphilis, it can infect patients who received the transplant. Therefore, the safety management of tissues for transplantation is very important. U.S. and Europe
3. Management of the Public-Private Communication Channel; Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO)
Biopharmaceutical Industry Development Strategy Planning Group (Dynamic BIO) was launched in Septempber 2010. It is comprised of 5 parts (general planning, industrial support, training and public relations, international cooperation and R&D) to take the function as the control tower and maximize the effect of support given to biopharmaceutical industries. It is also making various efforts in collecting opinions and making quick decisions through public-private council for biosimilars, council for practical support of vaccine commercialization and manufactory support task force.
established the organizations and regulations to support the provision of safe tissues since the 1970s. The first human tissue transplant was done in 1972, when the Catholic University of Korea used human tissue (bone) to cure a tumor patient. Whereafter, 40 university hospitals extracted and transplanted the human tissues, such as bones, in the early 2000s. However, due to the absence of regulations and standard for tissue selection, there has been the risk of infection. The KFDA established the Advice for Safety Management of Human Tissue and Operational Guideline in February 27th, 2003, and the Human Tissue Safety and Management Act in January 20th, 2004 that was enforced from January 1st, 2005. The majority of approved national tissue banks usually extract tissues from the surgery and, less frequently, from brain-dead patient. However, domestic supplies are not enough to meet the demand. Therefore, majority of tissues are being imported
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every year. Imported tissues took up 78% of the total distributed tissues in 2010, reaches 21.5 billion won in import cost. The current condition of domestic production and import in 2010 is indicated in Table 5-4-3. Table 5-4-1 Major Uses of Human Tissues for Transplantation
Types Major Uses R econstruction of defected osseous tissue after the removal of the bone tuma Ligament reconstruction Artificial joint replacement Transplantation of skin and corium to cure the burn patient Transplantation of heart valves and blood vessel Transplantation of fascia to cure the urinary incontinence Transplantation of auditory ossicles Transplantation of demineralized bone to dental implant Cornea treatment using amnion
Table 5-4-3 Present Condition of Human Tissue Production and Imports in 2010
Class Total Total Bone
Cartilage Ligament Tendon Fascia 2,721 272 2 0 13,323 978 1,901 931 Skin 37,220 25,117 (including 703 export) Amnion 1,988 1,878 Valve 72 72
(unit : EA)
258,069 200,516
Orthopedics
12,345
110
Out of the total domestic output: 173,109 - Products that processed domestic tissues: 56,665 (from tissue banks and medical facilities: 3,286, from processing company: 53,354) - Products that processed foreign tissues: 116,444 (from processing company) Out of the total amount of production and imports - Transplantable tissues processed in Korea: 66% - Transplantable tissues processed abroad: 34% - Transplantable tissues extracted and processed in Korea: 22% - Total of "Imported transplantable tissues" and "imported raw tissues processed in Korea": 78%
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administration, human resources management, training, document management, quality control, evaluation and selection of donors, tissue sampling, tissue processing, storage, labeling, side effect report and tissue disuse, and etc. The administration is expecting the gap of the quality and safety management to be reduced. Human tissue has low frequency of immunological rejection unlike organs such as the heart and is available to be transplanted to many patients by a single donor. Hence potential contamination by infectivity factor (viruses, bacteria, fungi) cannot be ruled out even though medical history, visual symptoms of infection, blood test and bacteriological examination on the tissues are confirmed. So the KFDA is preparing the guideline for disinfection and sterilization of human tissue and planning to improve the safety of secured human tissue. It is also planning to conduct a research on the exports manufacturers (tissue bank) through document inspections and revision of standards because document screening is not enough to secure the safety. The KFDA also conducted researches to implement NAT tests for HIV, HBV and HCV, and GTP system for human tissue banks. NAT tests can reinforce the screening inspection for tissue donors, and GTP system can provide safe tissues. Based on the result of these researches, the guideline for the GTP was established in December 2010, and in the year, inspections on foreign tissue banks are being conducted to inspect collection, processing, storage, distribution and overall quality management of imported tissues. Current Korean tissue banks still require more experience and expertise in their operation. Hence, one large-scale bank in major locations should be established for stable supply of tissues. In 2007, the research to develop a pilot project to determine the scope and structure of large-scale tissue bank was initiated. The large bank can perform extraction, examination, processing and distribution of tissue in bulk. Plans to establish the region-based large bank will proceed through the review on above mentioned research of 2007. This investigation includes analysis of Korean tissue banks, condition of domestic donation, size and distribution map of major foreign banks, and clear understanding of strengths and weaknesses of the domestic banks. Lastly, classification codes of human tissue that fits the Korean circumstances were developed (Korean registration of patent, June 2010), in order to promote the effectiveness of banks tissue management and secure the safety of transplant patients. The KFDA is also planning to develop computerised systems for integrated management of human tissues.
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This manual also describes the raw material warehousing, storage management, final product manufacturing, and structural and management system for herbal medicine quality assurance.
05
Once the herbal GMP system is stably implemented, national trust will be recovered through systematic quality management and the improvement in its quality.
(2) O rganization and Operation of the Development Council for Natural Pharmaceutical Industry
Korea is entering the aging society, and support of government is being demanded to secure the biotic resources and safety of herbal medicine. The general and systematic support of the KFDA were hitherto insufficient. The KFDA also formed and inaugurated a Natural Pharmaceutical Industry Development Council in March 3rd, 2011, which government related organizations, industry and academia attended. The Natural Medicine Industry Council gathers for a meeting every quarter and its department every second month. Each department is responsible for policy development and system improvement, to support the natural pharmaceutical industry. Figure 5-5-1 O rganization Structure of Natural Pharmaceutical Industry Development Council
Director General of Biopharmaceuticals and Herbal Medicines Bureau (Chair)
System Improvement Department (Herbal Medicines Policy Division) Medicine Department (Herbal Medicinal Products Division) Standard and Specification Department (Herbal Medicine Research Division)
Total 3 Departments
Chair: Director General of Biopharmaceuticals and Herbal Medicines Bureau Departments : System Improvement Department, Medicine Department and Standard and Specification Department Department Directors : Government (Directors from Herbal Medicines Policy Division, Herbal Medicinal Products Division and Herbal Medicine Research Division) and General Director from the Private Sector Department Staff : ~20 people for each Deparment - Government : KFDA, Ministry of Health and Welfare, National Institute of Horticultural & Herbal Science - Private : Relevant Organization, Industry and Academia
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be eliminated. In addition, it is not mandatory for herbal material importers to equip inspection tools, making it difficult to ensure the quality of the medicines if products are not subjected to inspections. According to the import herbal materials examination method, only 395 of 540 items are on the list. By expanding the examination list to include herbs mentioned in the Korean Pharmacopoeia and the Korean Pharmacopoeia - Herbal Medicines, the potential counterfeiting is expected to be eliminated, and safe medicine be supplied. Table 5-5-1 Number of Imported Herbal Materials on the Inspection List.
2006 2007 2008 April 2010 December 2010 All items in the Korean Pharmacopoeia and the Korean Pharmacopoeia - herbal medicine (and crude drug)
(2) R evision of Standards and Test Methods for Residues and Pollutants in Herbal Medicines
Major contents of Standards and Test Methods for Residues and Pollutants in Herbal Medicines (amended on October 29th, 2010, KFDA notification No. 2010-75) are as follows: established the new pesticide residue limits for 10 items including licorice and included 43 items, such as oryzae fructus germiniatus, to sulphur dioxide residue tests. For pesticides that were newly registered in the guideline for safe use of pesticides to be used on herbs, uncontrolled use can occur if they do not have residue limits prepared in the Standards and Test Methods for Residues and Pollutants in Herbal Medicines. Hence, it was necessary to establish residue limits for each herb. This was also to promote the competitiveness of the industry through assurance of safety and enhancement of product quality. The testing standards of residual sulfur dioxide were needed to be established for the items, other than 265 items with the existing limit standards. 43 more items were selected through analysis and monitoring of residual sulfur dioxide with the expert advisory committee and general deliberation committee. Therefore, safety was secured through the rearrangement of residual sulfur dioxide that could be introduced during the processing of herbal medicines (briquet dry and sulphur fumigation).
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(3) E nactment of Regulations for Item Approval and Reporting of Herbal Medicine
Regulations for Item Approval and Reporting of Herbal Medicine was notified on May 30th, 2011 after its amendment proposals in December 10th, 2010. It combines relevant sections on herbal medicines from both Item Approval, Declaration and Evaluation Regulation for Pharmaceuticals and List Declaration Regulation for Herbal Medicines with Specifications. It is simplified and clarified the approval, declaration and evaluation regulations of natural pharmaceutical products to enhance the publics understanding and improve related regulatory processes. Main contents include the range of registration objectives, approval procedures (and reporting), safety, effectiveness, standards, screening method and registration of standardized herbal medicines. This enhanced the convenience of registration and reinforced the competitiveness of domestic companies. The KFDA is also collecting various opinions to develop an improvement plan for the registration procedures, regulation and rules revisions to support the development of herbal medicines. With various opinions and suggestion, regulations and policies will be consistently revised in order to improve the characteristics of herbal medicine.
trial program was 45 in 2009 and increased ~33% a year. There were 176 civil inquiries made in regards to clinical trials approval, displaying 24% increase compared to 2009. This reflects the industrys attention on the development of new natural medicine (Figure 5-5-3). Figure 5-5-3 N umber of Clinical Trial Approvals and Relevant Civil Inquiry of Natural Pharmaceutical Products
Cases 180 160 140 120 100 80 60 40 20 0 2005 2006 2007 2008 2009
Inquiries
clinical trials
2010
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based on the prescription, Banhasasimtang succus. Banhasasimtang succus is based on the prescription of Banhasasimtang of Donguibogami. It was only permitted as powder and granule until now, but now liquid forms are approved for the first time. Table 5-5-3 List of Approved Herbal Medicine in 2010
Nu -mb -er 1 Type Company Product Name Ingredient Approved Effect Note
Dec 12 Infant respiratory prescription 2010 distress syndrome Blood circulation disorder (arteriosclerosis)
2
Medicines for Organ System 67%
Garlic oil/Crataegus Dong-A Oxyacantha 60% Jan 18 Pharmaceutical Circuran Ethanol ext./Melissa produced 2010 manufacturer Tab. leaf ext./Ginkgo flavon Co. Ltd. ext. Steleophaga plancyi Boleny/Aconitum ciliare Decaisne/Nux Vomica/Rhubarb/ Dalbergia odorifera/ Zanthoxylum piperitum De Candolle/Scutellaria Hwata baicalensis / World one analgesic Imported Phellodendron trade ointment amurense/Reynoutria japonica/synthesized Dryobalanops aromatica GAERTNER/ Peppermint oil/ dl-kampa/Methyl Salicylate/L-menthol produced Dong Wha Pharm. Co., Ltd Enter Pharm Co., Ltd. Enter Pharm Co., Ltd. Viofive granule Nova cole Fibrilar Nova cole Pad Psyllium powder/ Alexandrian Senna fruit powder/nicotinic acid amide/lactomin Absorbable collagen Hemostats Absorbable collagen Hemostats
Nonprescription
201002-02
Tablets 50%
Liquids 17%
Constipation and symptoms Hemostasis assistance for surgery Hemostasis assistance for surgery Diet adjurvants for secondary prevention and decreasing triglycerides
Imported
In terms of medical effects, there were 8 medicines for organ system, taking up 67%, metabolic medicines had 3 items taking up 25%, and medicine for sensory organ had 1 item taking up 8%. When arranged by form, there were 6 items in tablet taking up 50%, 2 liquids items taking up 17% and 1 item for each of injection and drops. Most of the approved items were crude drugs, and there is 1 produced item approved
7 6 Import
May 7 2010
Prescription
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Nu -mb -er
Type
Company
Product Name
the quick modification of approval regulations that fit rapidly growing medical and
Ingredient Approved Effect Note
pharmaceutical industries. Lastly, the KFDA prepared a task force team to carry out all the mentioned achievements in consumer and industry-focused manner.
Imported
Yuyu Umckamin Pelargonium sidoides Sep 17 Pharma, solution ext. 2010 Inc. Ripidem Inj. Middle chain triglycerides/Refined soybean oil/Omega-3 acids triglycerides
(3) R evised Approval Regulations to Facilitate the Development of Various Dosage Forms
The activity of herbal medicine industry was decreased after drug prescribing and dispensing became separated. To recover its past vitality, experts noted that traditional medicines need to be combined with modern pharmaceutical technology, moving on from their usual dosage form of tablets or powders. The KFDA amended burdensome regulations for screening data submission (grade
10
Iberis amara 50% ethanol tinc./Angelica root 30% ethanol tinc./Matricaria flower 30% ethanol tinc./ Caraway fuit 30% ethanol tinc./Milk Iberogast Thistle 30% ethanol Nov 12 2010 tinc./Chestnet leaf solution ethanol tinc. 30%/ Peppermint leaf 30% ethanol tinc./ Chelidonium majus Linne 30% ethanol tinc./licorice 30% ethanol tinc. pinellia/scutellaria baicalensis/ginseng/ licorice/jujube/ dried ginger/Coptis Chinensis FRANCH root liquid paraffin/light liquid paraffin
Gastrointestinal disorders
Prescription
of clinical difference test, biological parity test and etc.), which can create barriers, to offer more reasonable data scope for the relevant industries. Also, basic regulations were established to prepare for future amendments in approval regulations by forming an expert council with the pharmaceutical industry experts and the KFDA officers.
11
Iksubanh Iksu asasim produced Pharmaceutical -tang Co., Ltd. solution Bausch & Lomb South Asia Inc.
Dec 23 2010
Nonprescription
12
Imported
Dec 24 2010
Nonprescription
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guideline describes the Herbal Medicine Diagonostic Standards of Lower Back Pain and Criteria to Assess Effectiveness of Herbal Medicine. This guideline was introduced and distributed through presentations, press release and homepage. This is the first guideline handling the herbal clinical trial of chronic lower back pain scientifically and reasonably, marking its significance. The administration will continue to develop the guideline by documenting further researches on safety and efficacy of herbal medicines. Guideline for Clinical Trials of Herbal Medicine
Guideline for setting up Chemical Ingredient Profiling of Herbal Medicine It is generally difficult to identify all the chemical structures and properties of herbal medicines produced from natural materials because it contains a wide range of compounds. Although some of active ingredients and correlation between the ingredients and affects were identified, it is not always possible to identify such correlations. So far, the method that manages the active component has been used only if the active component is revealed and possible to be standardized. If the active component is not yet to be identified or its analytic sensitivity and accuracy cannot be assured, a standard for a representative substance with similar property was used. Nonetheless, majority of cases are not even possible to set a representative index. Therefore, the key point of herbal medicine quality management is to control the uniform proportion of the compounds. Chemical profile is a comprehensive and consistent information of chemical properties of herbal medicines. Its purpose is to secure optimum quality and homogeneity of effects and quality by identifying and managing the valuable properties to assure safety and effectiveness of the medicine. This guideline contains the appropriate examples along with the object, scale, assurance and verification method of the Chemical profile. It also suggested the
Efficacy tests for medicines include data to confirm their safety and efficacy. The data required for the submission must prove pharmacological mechanisms of the effect expression. In case of herbal medicines, it is not easy to establish experimental models suitable for such purpose and evaluate the results accordingly. The guidelines for 'atopic dermatitis', 'allergic coryza' and 'systemic lupus erythematosus provide recommendations to researchers in terms of test methods and examples, with the consideration of herbal medicinal properties, to bring out objective and fair results. The KFDA collected opinions and suggestions of the public and industry to publish the guidelines. It was also provided to the public through presentations, press release and homepage upload.
methodology that assures the quality of confirmed effects and the equability of the manufacture's serial number. This guideline was introduced and distributed through the presentations, press release and homepage. Other Activities On November 11th, 2010, the KFDA hosted a presentation on Approval and Evaluation Policy of New Natural Pharmaceutical Products at Grand Hilton Hotel Korea to support the commercialization of new natural medicine and strengthen its global competitiveness. At the presentation, submission range and time of nonclinical trial materials were accounted for the approval of a clinical trial program. Also, explained was the evaluation method that secures the quality parity, and the
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results of standardization of herbal medicine(research conducted by the KFDA) were introduced. The presentation was attended by ~300 persons and was considered as an event that supported the nature-based pharmaceutical industry.
Improvement of Processing Capability for Approval and Evaluation of Natural Medicine To improve the processing of civil inquiries, the KFDA is planning to standardize approval and evaluation regulations to resolve the confusion in the civil service, and reduce the recurrent demands for the supplementation by activating the two-way communication. The KFDA will organise a practical research group for natural medicine. It will expand the education and training to improve the evaluators capacity and expertise, and specify the role sharing and cooperation procedures in natural medicine approvals. Also, the Approval Adjustment Council for Natural Medicine will be formed to revise and strengthen current standards in approval and evaluation. Also, the civil service consultation history managing system will be established and question and answer on natural medicine will be published to enhance the two-way communication with the public.
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1. C onditions and Prospects of Biopharmaceutical Products Administration 2. S ystem Management of Biopharmaceutical Quality Assurance 3. F ostering the Biopharmaceutical Products and Building the Foundation of Support System 4. Safety Management of Human Tissue 5. Reinforcement of Safety Management Infrastructure for Medicine and Herbal Medicine 6. Establishment of Management System for Cosmetics and Sanitary Aid
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upon the human body. Quasi-drugs have less concerns on misuse or abuse, and are expected to keep their safety and effectiveness intact without prescriptions are written out by doctors or dentists. It includes about 30 items such as sanitary pads.
06
Actual output of quasi-drug is 1.1 trillion won, showing 12% growth compared to the previous year. Figure 5-6-1 Production Output of Domestic Cosmetics Industry
6,000 (Unit : billion won)
5,169
5,000 4,000
3,436 3,980 4,073
4,720
3,692
(Unit : 1,000US $)
845,996
2006
2007
2008
2009
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2. Establishment of Foundations for Safe and Appropriate Use of Cosmetics and Quasi-drugs
1) C omparison and Review of Domestic and Foreign Hazardous Substance Management Policy
The KFDA reviewed and amended 1,651 policies for Cosmetics and 223 policies for Quasi-drugs through the project to advance standards and specification (July 31st, 2009).
2010). The amendment stipulated the cosmetic products to label 12 substances, including formaldehyde, to raise the awareness of consumers in hazards associated with cosmetic products.
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p-formaldehyde and phthalate, to resolve the publics concern and support the industry.
2) Cosmetics and Quasi-drugs Surveillance 3) E stablishment of Guideline for Cosmetic Indication and Advertisement
After the recent coverage of the cosmetics that contained illegal steroids, dissatisfactions and doubts have been amplified due to the absence of regulations, confirmation object and method, labelling and advertisement. The KFDA established and implemented the guideline for indication and advertisement by receiving opinions from industries and organizations. This guideline is expected not just to secure consumers trust, but also to lay the foundation to improve the domestic cosmetic industrys international competitiveness. To build a basis of safe production and distribution management for cosmetics and quasi-drugs, the KFDA annually establishes the Basic Plan for Production and Distribution Management to set the general direction of product surveillance and conduct post-managment. The general direction of surveillance for 2010 was to strengthen autonomous review of policy application and management by relevant industries. It also implemented the focused surveillance on unreported and companies that did not meet the given standard. If the company produced improvement methods through self-assessment, the KFDA gave exemptions in enforcing administrative measures. It aims for the efficient post-management through the joint surveillance with KFDA head quarter, regional KFDA and local governments. In the field of cosmetics, focused inspections included surveillance of prohibited and controlled substances and sellers misconduct. The products that received this surveillance were products for children, color make-ups, and nail and toenails. In the field of quasi-drugs, the KFDA improved the inspections on manufacturing and recall/discard processes. For companies subjected to GMP, the KFDA confirmed
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their progress in product validation, which began from 2010, and provided trainings for companies that did not meet the standard. Table 5-6-1 Surveillance Results for Cosmetics and Quasi-drug Manufacturers and Importers (2010)
Infringement Details Type Cosmetics Quasi-drugs Company 566 294 Subtotal 385 231 Quality Inadequate Labelling and Standard management equipment Advertisement document 57 36 10 4 241 87 11 10 Other 66 94
(Unit : EA)
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were prohibited from being used in cosmetics. The KFDA prepared steroid detection methods and reference standard for cosmetic products, and distributed them to regional KFDAs, Institute of Health Environment of each city and province, organization to initiate relevant tests. The administration also collected suspicious items and conducted nation-wide inspections. Based on a report of products containing steroid distributed by a medical institution, the KFDA collected and inspected 50 products from 45 places, including hospitals and cosmetic shops. The inspection showed that steroid substances were found in 14 items out of 187 that were examined. The administration continues to conduct collection and inspections of cosmetic products (Table 5-6-2). Table 5-6-2 List of Cosmetics that Contained Steroids
No. 1 2 3 4 5 Company Di-Ves, Co. Di-Ves, Co. Di-Ves, Co. Jang's Cosmetics Withyou Herbal Biotechnology Institute Product Pine Topy Moisturizer & Soothing Cream Pine Topy Moisturizer & Soothing Cream Pine Topy Moisturizer & Soothing Cream Damil Multi herbal Cream Doduwon Composite Herbal Cream Serial number (Packing date) 100729A (2010.7.30) 100809A (2010.8.9) 100210 (2010.2.10) DH100702 (2010.7.17) Name of the Steriod Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Clobetasol Propionate Triamcinolone aceto nid (2010.7.29)21Prednisone Acetate Triamcinolone acetonid (2010.6.28.)21Prednisone Acetate Triamcinolone aceto nid Content (g/g) 49 41 14 23 4 23 21 45 95 40 67 17-Betamethasone Valerate F011 (2010.6.12) 21-17Betamethasone Valerate 1,064
No.
Company Peauciel Cosmetic Co., Ltd. Dong Sung Pharm Co., Ltd
Product
Name of the Steriod Triamcinolone Acetonide (2010.6.17)21Prednisone Acetate (2008.12.15) Triamcinolone Acetonide Triamcinolone Acetonide (2010.2.2)21Prednisone Acetate 17-Betamethasone Valerate 17-Betamethasone Valerate
10
Skin Top
11
AC HAHA Cream
DC10HL01
12
I-Natural Cosmetic
13 14
submarginal
Happy Cosmetic
Glaube Cream
AG2306
Noa-K1
DD76JI02
Atohhaha Cream
DC08JF01
Cleans Cosmetics
15
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Figure 5-6-3 Current Condition of Annual Evaluation (Including Reported Items) for Functional Cosmetics
Number of items 2,000 1,500 1,000 500 0 2005 2006 2007 2008 2009
The report system will be expanded to products with secured safety and efficacy. The KFDA is going through necessary processes in preparation, by selecting suitable items. It is expected that the administration will focus on cosmetics with dual-functions.
2) Establishment of Foundation for Enhanced Quality Assurance and Realiability of Cosmetics and Quasi-drugs
Approval and evaluation policies for cosmetics and quasi-drugs were improved, and regulations/guideline for the safety, efficacy and quality assurance of these products were amended. Major content includes the suggestion of Guidelines of Analysis of Hazardous Substances in Cosmetics, allowing the quality management of adventitious toxic substances by the industry. Also, multiple guidelines, such as the use standard for carbon black and testing method for the active substance in hair tonic, were
It is difficult to manage evaluation of functional cosmetics with limited human resources. Hence, the KFDA revised the evaluation system to enable the electronic document system for the reporting of those functional cosmetics with both previous item approvals, and assured safety and efficacy. This system decreased direct evaluations of products although the items listed as functional cosmetics are increasing. This allowed the KFDA to focus on the evaluation of substances that need professional reviews or items with specified administration or forms. Figure 5-6-4 Evaluation/Reporting Status per Year
Number of items 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 2008 2009
Evaluated items Reported items
established to invigorate cosmetics and quasi-drug industry. Table 5-6-3 Achievements in Improving the Reliability of Cosmetic and Quasidrugs
Achievements Details Review of assessment results for the safety of toxic substances such as Assuring Safety and formaldehyde Managing Adventitious Revision of regulation on designation of cosmetics raw material Hazardous Substances Revision of guideline for analysis of cosmetic formula in Cosmetics Revision of guideline for analysis of toxic substances in cosmetics Improvement of Cosmetic Colouring Standards Usage standard of Carbon Black Establishment of guideline for Carbon Black testing method Proposal and Notification for tar colour types, standards and test methods used in cosmetics
Preparing guideline to select test items in forming quasi-drug test Preparing Guideline for methods and standards Quasi-drugs Preparing the guideline for hair tonics active substance measurement Preparing the guideline for the specification of quasi-drug additives Preparing the Guideline Preparing the manual for cosmetic standard testing methods for Securing the Safety Preparing the guideline for repeated dose toxicity test method of cosmetic and Quality of Cosmetics
2010
Operating consultation group for specifications of cosmetic raw materials Operating Consultation Operating consultation group for SPF (sun protection factor) measurement Group for Cosmetic and standard Quasi-drug Standards Operating consultation group to prepare for quasi-drug standards and specifications
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4) P ublication of Promotional Material for Safe Use of Cosmetic and Sanitary Aid
The KFDA published a leaflet on Various effects of quasi-drugs to promote safe use of quasi-drugs. Also to secure childrens safety, notice on childrens cosmetics and childrens toothpaste choice and oral health care were distributed to the schools. Figure 5-6-5 Promotion Material for the Use of Childrens Cosmetics
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Chapter 06
1. The Condition and Direction of Medical Devices Safety Control 2. Improvement of Medical Devices Pre-Management System 3. International and Scientific Approaches to Medical Device Standards and Specification 4. Establishment of Medical Devices Quality Management System 5. Strengthened Post-Management of Medical Devices
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digitalization, networking and the introduction of U-healthcare for electro-medical devices based on technological advances in IT, BT and nanotechnology (NT). In tune with advances in medical devices development technologies, Global Harmoniztion Task Force (GHTF) was established, with US and Europe playing a leading role. This was to minimize the differences in approval systems and standardize management systems between countries. GHTF has achieved many results since its establishment and continues to organize active discussions between involved countries.
01
values.
1. Policy Environment
The importance of medical devices is in both domestic and foreign settings, being recognized as a new growth engine and a key industry in the enhancement of public health. Furthermore, the introduction of medical devices that converges information technology (IT) and bio technology (BT) is identified as an industry with high investment Korean government selected medical devices as a new growth engine, owing to the remarkable development of IT industry, and subsequently established focused development foundation. It is currently expanding its newly developed medical device market with technology convergence to the field of hospital informatization, and home & mobile and ubiquitous healthcare (U-healthcare). Based on the expansion of medical devices market and increase in product demand, consumer-focused post-management, provision of safety information, and preparation of an environment that allows sale or use of safe medical devices by the public are being highlighted as well as the governments support in promoting the growth of its industry.
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Table 6-1-1 World Medical Devices Market Size According to Geographical Locations (2010~2014)
2010 America Asia/ Pacific Asia/ Pacific Middle East/ Africa Western Europe Total 106,507 42,850 11,175 5,261 70,428 236,221 2011 110,753 46,619 12,279 5,692 74,176 249,519 2012 114,989 50,598 13,532 6,140 80,108 265,367 2013 119,001 54,740 14,614 6,643 86,359 281,357
(unit: million dollars, %)
Rank 7 8 9 10
Rank 17 18 19 20
Annual Growth Rate (average) 3.8 7.7 8.6 7.3 6.5 5.7
World market
Note 1: The market scale of Korea (Production Exports + Imports) deduced by referring to medical devices production report Note 2: The decrease of Korean market scale in 2009 was affected by the exchange rate fluctuations in 2009 (the basic exchange rate in 2008 : 1,102 won, the basic exchange rate in 2009 : 1,276 won) Reference: The Handbook on Medical Devices Production, Import and Repair Companies (Statistics), Korea Medical Devices Industry Association, 2010
Notice : Estimation of Espicom Data : Espicom, The World Medical Markets Fact Book 2009
The most notable country with the prospect of displaying rapid market growth is China. According to the statistics, (Table 6-1-3), China is expected to grow by 10.9% annually from 2010 to 2014. Its market size to increase from 6.9 billion dollars (2.9%) in 2010 to 10.4 billion dollars (3.6%) in 2014. Its market scale is also expected to rank up from 7th in 2010 to 6th in 2014. Following Chinas rapid growth in the medical devices industry, its market share in the global market will continue to develop. This will result in more intensified competition between the Korean and Chinese medical devices industries.
According to Espicom, the medical devices market size of America was at 92.6 billion dollars (39.7% of the world market) in 2009, becoming the largest market in the world. It was followed by Japan, Germany, France, Italy and China. The 10 largest countries shared 77.1% of the global market. The market size of Korea in 2009 was 2.86 billion dollars (1.2%) and was scaled at 13th. Table 6-1-2 The Medical Devices Market Size According to Countries (2009)
(unit: million dollars, %)
Table 6-1-3 The Estimation of Medical Devices Market Scale for Each Country (2010 ~ 2014)
2010 Country America Japan Germany France U.K. China Italy Market scale 94,448 24,270 18,059 9,425 8,259 6,943 8,593 Sharing 40.0 10.3 7.6 4.0 3.5 2.9 3.6 2011 97,695 25,951 18,844 10,045 8,078 7,720 9,000 2012 101,046 27,713 19,913 10,726 9,378 8,526 9,438 2013 104,418 29,361 21,026 11,384 11,011 9,374 9,838 2014 108,090 30,061 22,117 11,924 11,406 10,489 10,109
(unit: million dollars, %)
Rank 1 2 3 4 5 6
Rank 11 12 13 14 15 16
Annual Growth Rate (2010~2014) 3.4% 5.5% 5.2% 6.1% 8.4% 10.9% 4.1%
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2010 Country Spain Canada Swiss Total of 10 countries World medical devicess market scale Market scale 5,349 5,318 4,281 209,628 Sharing 2.3 2.3 1.8 88.7 2011 5,770 5,876 4,462 220,931 2012 6,240 6,333 4,722 234,425 2013 6,695 6,571 5,058 248,053 2014 7,132 6,896 5,376 259,302
Annual Growth Rate (2010~2014) 7.5% 6.7% 5.9% 5.5% Rate of imports depen -dence
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
64.8
60.3
65.6
64.0
61,0
59.5
61.4
64.7
65.8
67.5
Note 1. Value in bracket shows differences compared to last year Note 2. Market scale is calculated by production-exports+imports Note 3. The exchange rate for imports/exports use the basic exchange rate of annual average from the Bank of Korea Reference: Report on Medical Devices Production, Import and Repair, Korea Medical Devices Industry Association
236,221
100.0
249,519
265,368
281,357
294,377
5.7%
2002
2003
2004
2005
2006
2007
2008
2009
2010
11,941.0
13,481.3 13,271.1 14,781.7 17,041.6 19,491.6 22,169.7 25,252.0 27,642.6 29,644.4 (12.9) (-1.6) (11.4) (15.3) (14.4) (13.7) (13.9) (9.5) (7.2) 5,777.2 (0.4) 6,520.4 (6.1) 7,160.3 (9.8) 7,810.4 (9.1) 9,590.9 12,481.4 15,190.3 16,813.1 (22.8) (30.1) (21.7) (10.7)
11,722.2 13,592.9 14,708.0 15,461.1 17,193.2 20,014.2 23,408.8 23.988.1 26,613.9 (2.7) (16.0) (8.2) (5.1) (11.2) (16.4) (17.0) (2.5) (10.9)
-5,945.0 -7,446.3 -7,446.3 -8,300.8 -9,382.8 -10,423.3 -10,927.5 -8,797.9 -9,800.8 Trade -5,658.2 (5.1) (25.3) (25.3) (1.4) (13.0) (11.1) (4.8) (-19.5) (11.4) Balance Dome 7,704.2 -stic 6,187.2 (24.5) Demand Market Size 17,599.2 7,124.5 (-7.5) 8,261.2 (16.0) 9,881.4 11,681.2 12,578.8 12,770.7 12,452.3 12,831.3 (19.6) (18.2) (7.7) (1.5) (-2.5) (3.0)
19,426.4 20,717.4 22,969.3 25,342.4 28,874.4 32,593.0 36,179.5 36,440.4 3,9445.2 (10.4) (6.6) (10.9) (10.3) (13.9) (12.9) (11.0) (0.7) (8.2)
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clinical trials policy and regulations to level with international standards. The KFDA is also developing clinical trials programs to train experts to involve major domestic companies in medical devices industry and assist existing devices companies to enter the global market. The KFDA will also focus in establishing a productization base and support system for efficient productizations of new technology medical devices. This includes selecting domestic endobot technologies with productization date near, to assist them in policy procedures and provide them with relevant information in approvals, such as clinical trials, safety & efficacy assessment and GMP inspections.
2) P romoting Medical Devices based on New Technologies and Establishing International Competitiveness in Their Quality
Even through medical devices development is becoming more frequent, there is a delay in the devices productization and introduction to the global market due to lack of infrastructure in clinical trials that are essential in confirming safety and efficacy of devices, which incorporates new technologies. The KFDA is reviewing its
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1. The Condition and Direction of Medical Devices Safety Control 2. Improvement of Medical Devices Pre-Management System 3. International and Scientific Approaches to Medical Device Standards and Specification 4. Establishment of Medical Devices Quality Management System 5. Strengthened Post-Management of Medical Devices
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The KFDA unified the approval and evaluation process to simplify the tasks involved. The technical document review and item approval are now unified, minimizing unnecessary time taken during civil affairs. To simplify the system, each product type
02
3) Current Condition in Improving Major Tasks involved Approval and Evaluation System
The three bureau under the Medical Devices Evaluation Department (Diagnostic Medical Devices Division, Therapeutic Medical Device Division and Medical Materials and Supplies Division) are attempting to simplify approval and evaluation process, increase efficiency of approval management, internationally harmonize standard & specification and product categorization, and expand transparency and objectivity of approval and evaluation system. Introduction of Excellent Medical Devices Inspection System to secure (1) consistency and professionalism Operation of 3-Helplines (medical devices approval/evaluation conference) (2) Approval assistance system for products such as new technology integrated (3) medical devices Private sector consignment on technical document review of 2nd grade medical (4) devices Model operation of pre-assessment system on medical devices approval and (5) evaluation
1. Overview and Current Condition of Medical Devices Approval and Evaluation System
1) Overview of the Approval and Evaluation System
The technical document review of medical devices inspects the safety and performance of a device that integrates various advanced technologies, such as medical engineering, electroengineering, physics, chemistry, biology and material engineering. Hence it requires specialized experts from multiple fields of technology. Difficulties have been experienced in evaluations as a small number of experts are reviewing and assessing medical devices that incorporate technologies from various fields. Nonetheless, they are doing their best to handle fast-paced changes of the market environment under the aim of promoting the development of medical devices industry.
(6) Rationalization of sterilized medical devices review data (7) Expansion of approval scope on manufacturers performance data (8) Expansion of biological safety test exemption category (9) Conversion for 1st grade medical devices to submit list
Receipt
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unit, storage methods, service life, test specifications, and other relevant information. It is a requirement in item approval and is stipulated by Articles 4, 5, 17 and 18 of Enforcement Regulation of Medical Devices Act, and targets 2nd, 3rd and 4th grade medical devices as classified by Medical Devices Act. The review inspects the safety and efficacy of medical devices that were produced with integrated technologies. For this reason, the Medical Devices Evaluation Department is composed of experts from various technological areas, who assess different data to secure the safety and efficacy of these products. The KFDA established a common standard (KFDA notification) on electromechanical safety of medical devices that use general electricity. Also, a common standard (KFDA notification) on biological safety is for devices that are either inserted or comes in contact with the human body. Standards for individual products, such as blood storage container, are also developed to apply them in the review. In 2010, the KFDA conducted 4,483 reviews, and the pass rate and reject rate are 83% and 17%, respectively (Table 6-2-3). As shown in (Table 6-2-4), the major countries of import are Europe, America and Japan respectively. The imports from America and Japan have increased little to 988 (30%) of total imports, but imports from Europe and other countries were marked at 33% (1,090 cases). This shows diversification among import countries. Improving Medical Devices Technical Document Reviews The medical devices technical document is a technical document that confirms the safety and efficacy of products, and the technical document review is an essential procedure to evaluate the safety and effectiveness of products. These reviews require professional knowledge as they include product development principles, technical features and test reports. For these reasons, clear review standards and a direction in standardized technical document are necessary. The KFDA developed a measure to improve (proposed) the document review system in 2006 to harmonize with review systems of other advanced countries. For such standardization, the administration amended an overall structure of a technical document, introduction and test report formats, a conformity declaration form and a check lists.
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The medical devices, which were approved through safety-efficacy evaluation in 2010, are listed below. Figure 6-2-3 Medical Devices Approved through Safety and Efficacy Assessment
5. The Medical Devices, Which Were Approved through Safetyefficacy Evaluation in 2010, Are Listed below.
1) Explanatory Sessions for the Public
The active supply of relevant technical information at government level are essential for small-medium sized medical devices businesses. For this reason, the Medical Devices Evaluation Department organizes explanatory sessions, focusing on the needs of consumers. These sessions represent that the administration is shifting its focus from policy to the cooperation with the industry to promote their development and involvement.
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6. Provision of Technological Information and Method of Safe Use of Medical Devices for The Public
The KFDA published guidelines and technical document reporting methods for major medical device products to achieve a standardized and scientific, international harmonization and increase civil accessibility. The administration provided assistance to the public by increasing the predictability in the required documents for submissions and enhanced level of medical devices quality management.
2010.6.30 2010.5.24
2010.10.13 2010.11.16
1) Guides on Technical Document Review Preparation Published to Actively Provide Relevant Information to the Public
Guideline on medical ion therapy device approvals and technical document (1) preparation Guideline on magnetic resonance computerization tomography device approvals (2) and technical document preparation Guideline on dental material approval and technical document preparation (3) Guideline on electronic operational equipments approval and technical document (4) preparation Guideline on technical document preparation for medical image processor and (5) its software Guideline on technical document preparation for potential generator (6) Guideline on technical document preparation for extracorporeal shock wave (7) treatment device Guideline on technical document preparation for ultrasonic image diagnosis (8) device Guideline on technical document preparation for paraffin bathtub (9) Guideline on skin resistance measuring instrument approval and technical (10) document preparation Guideline on optometry refractive power measuring instrument approvals and (11) technical document preparation Guideline on technical document preparation for medical endoscope (12) Guideline on technical document preparation for medical scooter (13)
2) Medical Devices Committee Activities for Medical Device Safety and Efficacy Evaluation
The development of medical devices with new technology is increasing, following the development of scientific technology. Factors in medical device that affect on safety-efficacy are variable according to their individual features. Also, the number of products, which demands safety-efficacy assurance, are also increasing. In order to manage these products, the KFDA is operating a new development department committee within the medical devices committee. The major activities of new development department committee in 2010 are listed below. Hosting committee consultation for the review of the validity of clinical test data on tissue repair material for penis enlargement (Nov 24, 2010) Hosting committee consultation for the review of the validity of clinical test data on Cilostazol and Paclitaxel (Dec 15, 2010) The labeling of the products being used for serious aortic stenosis, which apply cardiothoracic surgery aorta valve substitution cannot be applied, as rare medical devices. (Dec 15, 2010)
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Guideline on technical document preparation for electric wheelchair (14) Guideline on technical document preparation for (electronic) thermometer (15) Guideline on technical document preparation for ultrasonic wave stimulation (16) device Guideline on technical document preparation for blood pressure gauge (17) Guideline on personal combination stimulation approval and technical document (18) preparation Guideline on personal super heater approval and technical document (19) preparation Guideline on artificial kidney filter approval and technical document preparation (20) Guideline on infrared light device approval and technical document preparation (21) Guideline on technical document preparation for gene amplification device (22) Guideline on airway hearing aid approval and technical document preparation (23) (24) Guideline on laser surgery item approval Guideline on technical document preparation for treatment device (25) Guideline for medical device performance test (26)
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1. Overview
Korea is actively participating in a Global Harmonization Task Force (GHTF), which was led by 5 advanced countries (America, Japan, EU, Canada and Australia), to achieve international standardization of domestic medical devices technology and international harmonization of its management control system. In 2006, the KFDA hosted Asian Harmonization Working Party (AHWP) in Korea. Although the KFDA is preparing its management standards to meet international levels by specialized item categorization and reorganization, an establishment and amendment of its current standards and specifications became necessary to develop domestic technologies and enhance competitiveness of the industry.
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standard information database system on the KFDA website, which is identical to the Recognized Consensus Standards' of the American FDA, to provide the necessary information for the development and approval of medical devices. Figure 6-3-1 Provision of Information on Standards Applied for Medical Devices
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to certify that the device is safe, effective, conforms to its intended use and be produced in a consistent manner. In Korea GMP system was introduced in 1997, as a recommendation by High Quality Medical Equipment Production and its Quality Management Standard, during which medical devices were managed by the Pharmaceutical Act. GMP system became mandatory from May 30th, 2004, after the introduction of Medical Devices Production, Import and Quality Management Standards published based on ISO 13485 as a part of the Medical Devices Act. Hence,
3. Future Directions
The KFDA will continue to develop new assessment technology that reflects the scientific development and addresses safety assessment methods. It will also develop and apply standards and specifications for various medical devices. Furthermore, they will revise existing individual standards for their international harmonization to assist in the enhancement of national health.
any medical devices manufacturer, medical devices importer and medical devices for clinical trials manufacturer that sell or distribute products without applying GMP system are subjected to administrative measures.
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an information section for GMP was prepared for businesses and industries in KFDAs website, providing relevant information such as guidelines, related data, risk management, validation and technical assistance. As a result, a total of 3,291 companies, 1,838 manufacturers and 1,453 importers, received GMP certification to December 2010.
(1) G MP Operation Guideline for Small to Medium Sized Medical Devices Manufacturers
The guideline for GMP operation and application cases is suitable for small-medium sized manufacturers that shares 80% of domestic medical device manufacturers. It was aimed to help early implementation of GMP system and enhance its operation.
Pre-evaluation
The KFDA applied high level quality management techniques, such as risk management, sterile validation and software validation, as a mandatory requirement since May 31, 2007. The administration applied ISO 14971 as a risk management method similar to other advanced countries. The KFDA has also been conducting customized technological assistance for overall application of GMP, focusing on the risk management and validation, since 2008 to improve current GMP operation status to the international standard and to establish a solid basis for high performance medical devices productions.
Main evaluation
Decision making
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fit to international settings. Furthermore, adequate education on risk management, sterile validation and software validations, which are high level quality management methods, should be taught to relevant businesses. Hence the KFDA has developed various educative contents and specialized GMP education programs.
The GMP mark system is a quality assurance system, which was introduced in June 2007, to allow easier identification of products that received GMP certification by the consumers. The GMP mark is labeled on the products of manufacturers, which received the GMP certification, and can help to improve qualities of distributed medical devices through the GMP Mark elimination of unmarked products. Furthermore, it is expected to improve the quality of imported medical devices once on-site inspection for foreign manufacturers are implemented and above mark provided. The KFDA is planning to develop a GMP mark system similar to the CE mark of EU.
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1. Overview
There was a sudden increase in the demand of home medical devices due to changes in cultural trend and rapid development of medical devices industry after the implementation of Medical Devices Act in May 2004. This led to sales and distribution of defective and fraudulent medical devices. The KFDA is actively engaged in the crackdown of unregistered devices, collect and inspect defective devices and supervise that advertisements for medical devices are not false or exaggerated to protect consumer health and relevant industry. The KFDA also prevent possible hazardous implication by collecting medical device adverse events reports from within and out of the county, which in turn are released to the public. Figure 6-5-1 The Basic Direction of Medical Devices Post-Management
The Basic Direction of Medical Devices Post-Management
Improvement of crack down efficiency : Termination of regular monitoring Switching to the autonomous check-evaluation system The reinforcement of planned monitoring on the problem reported products Securing quality of distributed medical device : Performing of the quarterly non-scheduled collecting-examination Extermination of false-exaggerated advertisement : Operation of special agents on illegal advertisement monitoring Safety re-confirmation of distributed medical device : Implementation of re-evaluation on medical device (2 times) Activation of safety information including side effect report : Establishment of activation measure including expansion of safety information training Management of trace-targeted medical device : Adjustment of designated target and inspection on current status of control
population, are causing concerns in regards to possible consumer health implications. The KFDA introduced medical devices advertisement pre-assessment system in 2007 that enforced mandatory review of advertisements made on daily newspapers, monthly magazines, television broadcasts and internet. In the late 2010, a total of 1,801 reviews were completed to exterminate misleading or exaggerated advertisements and to establish reasonable standards for effective response to products, whose advertisements were not reviewed. In 2010, the KFDA completed joint crackdown on companies that sold unauthorized medical devices with regional KFDA and government. These companies especially targeted senior citizens, giving them free trials of the devices and providing false and exaggerated advertisements. A total of 105 companies were caught during crackdown that was conducted twice, one early and one late during 2010. Another example of strengthened post-management system is the employment of medical devices monitors that surveys advertisement sources such as newspapers and the internet, to check for false and exaggerated advertisements. Also, an inspecting medium has been designated at each of the regional offices, to prevent duplicated inspections. These measures show effective mechanisms of which the KFDA employed to strengthen post-management of medical devices.
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Figure 6-5-2 Illegal Medical Device Advertisement Caught in the Last 3 Years
Year exposure (case) 2008 233 2009 278 2010 444
the reports for other businesses, and prevent hazardous factors in advance. The KFDA established internet reporting system through K!FDA network to assist the publics accessibility. Medical Devices Safety Information Reporting including Adverse Events shows that cases have increased by 5.7 folds in 2009 compared to 2008. In case of 2009-2010 comparison, it has increased by 6%. Figure 6-5-3 S afety Information Reporting Status (Inc. Domestic Adverse Events Reporting) in the Past 4 Year
2500 2000 1500 1000 500
autonomous collection side effect report safety information
The KFDA is to uncover issues in the advertisement pre-assessment system for its successful implementation and update assessment results on its website for the public access in 2011. It will cooperate with the Korean Senior Citizens Association to prevent fraudulent cases of medical devices affecting vulnerable citizen groups, such as elderly or women population. The KFDA will also be actively engaged in educating and promoting associated risks, to minimize complications due to misleading advertisements.
2) P revention of Risk Factors in Medical Devices: Adverse Events Reporting, Trace Management and Reassessment.
Current trend in medical devices is that the use of personal and higher-risk medical devices, such as ones that get inserted into a human body, are increasing due to ones interest in maintaining healthier life and advances in medical device technology, respectively. Finally, changes in cultural trend caused the public be more alert about the product safety. Since the initiation of Medical Devices Act, the KFDA is continuously revising relevant regulations and employing experts to prepare suitable environment for the effective medical devices safety management, especially for in assuring safety and efficacy of the devices. Furthermore, designation of trace management devices, adverse effect reporting and medical devices reassessment are tools established for efficient postmanagement of medical devices. By utilizing these tools, the KFDA will be able to prepare preventive management for distributed medical devices and enhance relevant domestic industry standards. The safety information report system, such as adverse event reports, allows those who handle medical devices to recognize the associated issues autonomously. The KFDAs role is to review such issues and prevent additional complications by relaying
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According to the Medical Devices Act, medical devices can cause critical damage to the human body during the usage from their adverse effects or faulty functions. Hence, devices that require trace-work has been designated to be managed through written records. This is done by the medical device manufacturers, importers and sellers and by those who opened the medical businesses. Until recently, the KFDA managed 8 products as trace-management targeted medical devices. It recognized that implantable cardiac impactor electrode and cardiac impactor needed to be designated as trace-management targets, and were added to the list subsequently (KFDA notification 2008-85, Dec 30, 2008). The administration also eliminated or decreased irrelevant products from the list. Minimizing Targeted Medical Devices (May 29, 2009) - Elimination of external artificial cardiac pacemaker and minimization of implantable medicine impregnator products
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For the last 3 years, 2,969 reports on domestic safety information were made although it is still insufficient compared to reports made in the US and Japan. This largely due to insufficient awareness of the person in charge on medical devices and the difficulty to determine whether the occurred adverse event is a target of reporting or not. The KFDA will expand its education and training programs, and establish and provide Guidelines on Medical Devices Adverse Events Reporting to medical devices manufacturers, importers and healthcare workers. In 2011, the KFDA will establish a Medical Devices Safety Information Monitoring Center in 6 domestic medical organizations for active adverse events reporting. The administration is also to perform medical devices reassessment for 609 products, including soft contact lenses, which gained item approval before the implementation of common standard. The purpose is to reinforce national health safety standards through the elimination of risky medical devices from the market and promote distribution of high quality medical devices only.
The medical device which can be used outside of the medical organization from the life-support medical devices
Silicon gel implant breast The electrode for implantable heart impactor
item added (Dec. 30. 2008)
Heart impactor
The medical devices reassessment is a system built to reflect and manage strengthened standards and specifications, and address issues raised after the distribution of the product. In 2010, the KFDA arranged reassessments of 205 products, such as laser operators and electronic operators, which were authorized before the implementation of the common standard. Figure 6-5-5 Medical Device Reassessment Flowchart
Designation of target item The medical device committee review the target item, requested period, submitted papers.
Item illustration
Notify one by one by homepage or mail till 1 year before the re-evaluation
Re-evaluation application
Submit (request) the needed data for re-evaluation including copy of the item license certification
Notification of re-evaluation result on the item after the end of draft proposal reading
Follow up action
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Table 6-5-1 Medical Devices Collection and Assessment Records in the Last 5 Years
Class 2006 2007 2008 2009 2010 Products 117 137 145 289 251 Result Suitable 76 125 137 261 189 Non suitable 41 12 8 28 62
Required papers : Company current status card, check list, evaluation report Evaluation method : A ~ E (5 steps relative evaluation)
Since its model operation in 2009, the participation rate has increased (Table 6-5-2)
in 2010 as a result of civil presentations and regular training to improve participation rates. Table 6-5-2 Regional Participation Rates of Self Inspection Assessment
Class Manufacturing Import Repairing Total Total 996 833 695 2,524 Participation 676 675 414 1,765 Non participation 320 158 281 759 Participation rate compared to previous year 2009 49.6% 70.7% 31.6% 2010 67.9%(18.3%) 81%(10.3%) 59.6%(28%)
In 2011, the KFDA will request the entire medical device manufacturers and importers to conduct self inspection assessment. Based on the assessment result, any companies that did not participate or were deemed inadequate (trainings to be provided) will be given options for further surveillance and inspections to ensure the safety of products. The KFDA is also to implement Good Sales Practice (GSP), which is additional to GMP/GIP, for managing import and production and to manage issues raised during the sale and distribution of medical devices. GSP is to be followed by medical devices merchant and renters and will support the KFDAs aim to ensure safe trade and distribution of medical devices.
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1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. Improvement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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to final consumption stages of food preparation including manufacturing processes. Finally, risk assessment should build realistic exposure scenarios by considering various factors. However, in case of groups with higher sensitivity to harmful substance or display higher risks, the substances acute, chronic, accumulated and combined effects must be considered. For vulnerable groups such as pregnant women or children, a more careful investigation and analysis is required, and various circumstances should be considered when developing a scenario.
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1. Overview
Recently, determining health risks and establishing standards of foods, cosmetics and herbal medicines are gaining importance. This is due to the increased awareness of the public regarding their health and food safety based on enhanced standards of living. Risk assessment may function as a communication tool, and such a role is crucial in resolving the publics concerns on health risk factors. Furthermore, it can be served as a scientific basis in establishing policies for risk management. National Institute of Food and Drug Safety Evaluation (NIFDS) developed safety standards for food with health risk concerns and prepared grounds for risk assessments and new assessment technologies to strengthen its pre and post management to protect the health of the public. Relevant Act: Article 15 of Food Sanitation Act, Article 20 of Framework Act on Food Safety, and other Acts such as Pharmaceutical Affairs Act and Cosmetics Act)
based on relevant exposure data such as the amount of intake. - Risk Characterization: Describe the likelihood of human health risk in terms of risk index (in %), excess risk for carcinogenicity and MOE, based on results from two previous stages of Hazard Characterization and Exposure Assessment.
Chemical risk factors of foods, herbs and cosmetics: Pesticide residues, veterinary medicine residues, environmental pollutants, naturally-occurring toxins, mycotoxins, food additives, chemicals derived from containers and packages, and etc.
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For the purpose of increasing the publics perception of scientific facts behind food safety management, the NIFDS developed and provided risk communication contents in various format, including hazardous material handbook, smartphone application and theatrical plays. Furthermore, these contents were used to strengthen risk communication capabilities of laborers directly involved in food safety, and utilized as
3. Performances of 2010
The NIFDS performed 134 risk assessments for pesticide residues from food, food additives (tar color), heavy metals found in wine (lead, cadmium and the etc.), microorganisms (Staphylococcus aureus etc.) from marine products, nickel, aluminium, methylmercury and others from cosmetics. The NIFDS suggested provisional tolerable weekly intake (PTWI) and arranged a data integration program (MIMS) for hazardous material monitoring data of domestic food for risk assessment. The institute provided a casebook on food safety management from the regulatory agency of foreign countries such as USA, Japan and EU to support preventive safety management.
part of customized communication with specific groups. Risk Assessment Expertise Training was held twice in 2010 to exchange risk assessment techniques and foster experts by applying theories and practical trainings. The 1st training targeted officers from food and pharmaceutical sectors that were involved in risk assessment, and discussed Method to Select Optimal NOAEL of Hazardous Substance (I). The 2nd training targeted public officers and researchers from the Korea Food and Drug Administration (KFDA), and public health sector organizations established in various cities and provinces, respectively. The main subject of the training was Exposure Assessment for Hazardous Substances in Food . The NIFDS signed MOU with the German Federal Institute for Risk Assessment (BfR), a European agency specialized in risk assessment, to exchange information on integrated risk assessment, expertise, and to cooperate in relevant technologies. The NIFDS hosted an international symposium with a discussion on Present and Future
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Conditions on Risk Assessment for Food and Policy of Korea and Europe, to exchange and increase understanding of risk assessment techniques and its processes developed in various agencies.
BfR : Bundesinstitut fr Risikobewertung (Federal Institute for Risk Assessment)
foreign origin, and finally, establish a library of the reference food. In addition, the NIFDS will prepare a section on its homepage to upload domestic and foreign risk assessment information, aiming to promote the publics understanding of risk assessment procedures, evaluation and management. The NIFDS will develop and distribute different guidebooks on food poisoning prevention, preservatives and antioxidants, illegal substance analysis, food hygiene monitoring, and methicillinresistant Staphylococcus aureus (MRSA) in food and its hazard analysis. It is also to publish customized training manual for endocrine disrupter, and training material for cooking and general equipment washing methods.
The NIFDS hosted the Technical Workshop for Food Safety Risk Assessment in AsiaPacific Region with the subject on Combination of Methods for Risk Assessment, to strengthen the shared system for hazardous material safety management between Korea, China, and Japan. Likewise, it hosted an open forum on endocrine disrupters such as phthalate, for the purpose of providing accurate information and strengthening risk communication by education and training. Government agencies (the KFDA and the Ministry of Environment), NGO, and academic researchers participated in the open forum, and debated management practices to reduce the level of endocrine disrupter and to alleviate related anxieties and concerns. Developed countries are actively taking leading roles in conducting risk assessment for genotoxic carcinogens in food, such as PHA or aflatoxin. With a reference to relevant guidelines published by WHO and EFSA, the NIFDS prepared a guideline for risk assessment of genotoxic carcinogens. Moreover, another guideline for practical methods and processes required in risk assessment of specific hazardous factors in food, cosmetic and herb was published to enhance the reliability and efficiency of assessment results.
5. Expected Result
All practices of the NIFDS will facilitate the attainment of practical, fast and accurate risk assessment system by introducing steps for standardized risk assessment of each area and basis for scientific risk assessment. The NIFDS will continue to improve and protect the quality of public health, and promote national competitiveness by establishing policies that are based on risk assessment.
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1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. Improvement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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focus was made on the development and operation of the management system for quality assurance documents to address such need. The NIFDS established a system, which unifies standard work protocol forms, manages new entries, amends and
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compiles and history of documents, to prepare a professional and reliable operating platform. This enabled comprehensive management and efficient data search of quality documents on test analysis. Figure 7-2-1 M anagement Program of Documents on the Quality Assurance of Test Analysis
1. Overview
In order to obtain accurate test analysis results, there needs to be a system that can establish reliable detection techniques and testing procedures. For that purpose, the following procedures must be met followed guarantee the condition of test analysis. Assure quality of reference standards through strengthened management system for national reference standard that can be utilized as a reference standard during test analysis; Validate relevant facilities and equipments, and document and verify the result; Systematize the quality evaluation method of test analysis and instructions for facilities and equipments; and Document all steps of test analysis as a Standard Operating Procedure (SOP). Based on earlier objectives, the NIFDS established a system for continuous management of documents, verification of equipments, development and improvement of reference standard and method standardization, maintenance of international certification and preparation of crisis-response manual, meanwhile attaining the institutes international credibility.
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test analysis methods and standardization are being requested. The NIFDS developed and enhanced 183 test methods through continuous efforts and hosted training on the theory and practice in the distribution of standardized tests for the 52nd time. The training demonstrated the institutes reliability and professionalism. By preparing Emergency Manual for National Lot Release for effective response against emergencies caused by new endemics, the NIFDS developed testing methods that address public requirements and rearranged its system. The NIFDS verified the superiority of human breast cancer cell proliferation test method through an international joint validation study with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), for the purpose of validating search-test method for endocrine disrupter. Also by organizing practical workshop with OECD Endocrine Disrupter search-test method to share relevant technologies and train human resources, the NIFDS confirmed its ability to respond towards any global policy management.
1. B uilding Advanced Foundation for Scientific Risk Assessment Enhancement of Status as an International Institute for Test Analysis and Research 2. 3. P roviding Scientific Basis for Advanced License Screen System and Safety Management 4. I mprovement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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Providing Scientic Basis for Advanced License Screen System and Safety Management
information through the internet are increasing. Hence the public expectation towards responsibility of the KFDA in managing, approving, evaluating pharmaceutical products and promoting their safe use, has been growing steadily accordingly. The KFDA has been reviewing Study for Safety Management of Medicine since 2004 to achieve further development and internationalization for safety management scheme, evaluation, and general management system of drugs. Moreover, the NIFDS supports the supply of safe and high quality pharmaceuticals to the people by conducting out researches and developments to lay a scientific basis of safety management policy for drugs. The purpose of these examinations is to secure transparency, objectivity, fairness of pharmaceutical approval and evaluation processes. Furthermore, they aim to promote safe and correct use of pharmaceuticals. Major research topics in Study on the Safety Management of Pharmaceuticals of 2010 includes studies on standard, specification and quality assessments, safety and efficacy assessments, equivalence, enhancement of pharmaceutical management, evaluation and assessment, and methods to reinforce monitoring of adverse effects of pharmaceuticals.
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2) Major Achievements
(1) E nhancement of Pharmaceutical Standard, Specification and Testing Methods
Enhancement of Pharmaceutical Standard and Specification The NIFDS conducted comparative reviews on international standards on additives, active pharmaceutical ingredients and final pharmaceutical products to address its need in specification enhancement measures to achieve anticipative risk prevention of pharmaceuticals. In Korea, pharmaceuticals that are primarily or frequently used are managed according to the KFDA notifications such as The Korean Pharmacopoeia and The Korean Pharmaceutical Codex. The NIFDS compared and reviewed domestic standards and test items against advanced pharmacopoeia from foreign countries such as USA, Japan and Europe. In 2010, the NIFDS established new and revised existing test items with risk concerns and thereby developed 144 amendments (proposed). Enhancement of Test Although there are test methods described in notifications such as the Korean Pharmacopoeia, international harmonization and enhancements are continuously required by considering developments in analysis techniques, industrial condition, and level of science. The NIFDS consolidated testing methods and pushed for advances in testing methods of related compounds, simultaneous analysis of combined products, sterile test from general testing methods, microbial limit tests, and residual solvent tests. These were also included in notifications such as The Korean Pharmacopoeia, The Korean Pharmaceutical Codex and The General Test Method of the Korean Pharmacopeia.
Supporting Lot Release Test for Pharmaceuticals, Designation of Testing Laboratory, and their Inspections In 2010, the NIFDS examined 27 lot release testing against pharmaceuticals available in the market to verify their quality and safety. Likewise, the NIFDS also designated 5 laboratories to carry out consigned work for quality testing and conducted regular inspections.
(2) P roposed a Guideline for Pharmaceutical Approval and Evaluation, and Related Policies
The NIFDS reviewed and compared related regulations and literatures from both domestic and international sources, gathered expert views of the industry and academics, developed approximately 20 improvement proposals and evaluation guidelines for each screening assignment. These reports were forwarded to departments responsible for policy development to ensure transparency, objectivity, and fairness of drug license screening, and to harmonize with international standards. These improvements are expected to improve the understanding of new or existing drug development by pharmaceutical companies and regulatory officers, and generate positive effects such cost and time reduction for drug development, more systemized and scientific development process, and more effective drug evaluation by the KFDA officials.
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and medical specialist (3rd level customer). This established safer and more adequate control over drugs through bi-directional communication between customers and the information provider, the NIFDS. Update on the on-line Information Page on Drug Intake (http://medication.kfda. go.kr) The NIFDS created and provided video guides on proper drug intake method for different drug types, facts on drug intake for patients with liver or kidney disorders, facts on drug interactions, and method to read fact sheet included in medicines. Also, information on Over-The-Counter (OTC) is available in both Vietnamese and Chinese languages. Update on the Information Page with Reference to the Usage of Drugs (http:// opendrug.kfda.go.kr/drugsafeuse) The NIFDS uploaded materials to provide additional information on therapeutic effect and safety for frequently or commonly prescribed anti-fever/anti-inflammatory, antibiotic, cardiovascular and metabolic drug. Formation of a Database for Bioequivalence Test Data (for Project Plannings and Reports) and Update of the Elution Comparison Test Data on the KiFDA Web Site for Examiners The NIFDS formulated a database, enabling 20,819 bioequivalence test data to be searched for the KiFDA website, where the information can be accessed for future project design or reports.
3) Future Projects
(1) A dvanced Prevention Management through the Enhancement of Standard, Specification, and Test Methods of Pharmaceuticals
The NIFDS will analyze trends in drug standards and its international harmony by monitoring other countries, and regularly examining the enhancement in the drug standardization. The institute will fully support the protection of the national health care through the advanced prevention management, and be involved in resolving any public anxiety or concern over pharmaceuticals and their safety. The NIFDS will also prepare phase-based amendment (proposed) of testing methods that require revisions by 2012, through organizing various research projects.
(3) P roviding Safety Information on Drugs for the Socially Vulnerable Groups
It is a world-wide tendency to establish a safety-net for socially vulnerable groups. Also, the importance of preparing safety measure, while addressing the distinctive nature of each group, is being equally highlighted. The NIFDS will present revisions of related regulations, such as the introduction of pictograms, to enhance the integration of drug intakes in elderly, publish and distribute books with Braille and voice code for the visually-impaired, and booklets translated into different languages for multicultural families, to help improve their quality of life (proposed).
(4) R esearch for the Enhancement of Good Manufacturing Process (GMP) for Pharmaceuticals
The NIFDS organized an international training of WHO (World Health Organization)/ GLO GMP for 10 GMP inspectors from 7 different countries including the Philippines, Laos and Cambodia, for 9 days from March 9 to March 17, 2010. The institute also completed an English translation for Implementing Regulations of Pharmaceutical Affairs Law (Table 3), Quality Management Standard for Biological Products, and GMP related regulations, as a preparation for acquiring the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership.
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alimentary, and urogenital systems, and for allergy, antifungal, and anti-viruses. It is expected to provide information on safe and efficient use of drugs. It can also be referred during safety management actions invoked by adverse effect event for the analysis of cause-and-effect relationship.
2) Major Achievements
(1) Establishment of Tests for the Quality Management of Biopharmaceutical Product and Establishment/Revision of Related Regulations
For the improvement of biopharmaceutical national lot release testing, the NIFDS established quality management testing methods and prepared effective management system through newly establishing or revising related policies. In addition, a recording scheme of The Korean Pharmacopoeia for recombination medicine (interferon) has been arranged to provide the local industries with more accessible and effective in quality management that conforms to international standards.
(6) E stablishment of Side Effects Management System of Drugs in Accordance with International Standards
The NIFDS is to build localized drug monitoring centers in 20 different locations by 2011.
(3) D evelopment and Implementation of Internal and External Training Programs for Pharmaceutical Approval and Evaluation Procedure
To address the latest trends of the rapidly changing biological drug and increase efficiency in collecting relevant data, the NIFDS organized the Biological Medicine Examiner Course as a regulator training program.
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3) Future Plans
(1) F ormulation of Newly Standardized Local Products and Continuous Improvement of the Management System
In 2011, projects to establish national reference standards for nine blood coagulation factors and anti-tetanus human immunoglobulin will continue. Also, there will be continuous improvement in operating national reference standard development.
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management based on science. The NIFDS provided relevant departments with The Standards and Test for Nonmedical Products, revised (proposed) Regulations for Setting Raw Materials of Cosmetics and Amendments/New Standards for raw material and their specification for Quasi-drugs. These documents were produced by inspecting and conducting comparative studies with international specifications. They also aim to ensure specifications of cosmetics and quasi-drugs are in line with international specifications. The NIFDS developed advanced tests for hazardous substances for cosmetics and quasi-drugs closely related to daily lives of the public, where these substances may lack specific analytical method and possible cause issues and concerns. The NIFDS also performed quality tests on products already available on the market, which were collected to confirm their safety. The NIFDS is currently establishing a scientific foundation for safety management policies, based on a fast and accurate analysis and scientific risk assessment of hazardous substances, such as steroids, as safety issues of cosmetic products are becoming more frequent. The institute also designates institutions to conduct quality test of cosmetics or quasi-drugs, and assist the further research on actual cases. The demands to secure safety of daily household items, such as cosmetics, are increasing due to the peoples awareness on hazardous substances and knowing the different ways to protect them. The NIFDS helped educate people on cosmetic risk assessments for through the circulation of Information Newsletter on Food and Drugs and distribution of brochures. Furthermore, it provided Safety Information Service on Cosmetics to enhance the accessibility of fast and accurate data to consumers and related industries. In the future, the NIFDS is to revise standards (proposed) for items recorded on existing regulations, support approval, evaluate safety management of cosmetics and quasi-drugs through by establishing corresponding analysis method, and create a scientific risk assessment system to act actively against safety incidents or accidents of cosmetics and quasi-drugs.
2) Major Achievements
(1) Enhancement of Standards of Medical Devices
The KFDA is conducting studies to enhance standards for all type of medical devices. They began working on the enhancement of medical equipment standards in 2009, and accomplished 77% of the total workload. They revised of 7 chapters on The Common Standards for Biological Safety of Medical Equipment, which includes revisions for whole body toxins and transplant tests.
(2) F ormulation of a Basis for Evaluation Technique of New Medical Devices Technology and Radiation Safety Management through the Provision of Guidelines for Medical Devices Evaluation, and Manuals
The NIFDS improved the standardization, scientific approach, and internationalization of screening for technical documents of medical devices through publishing guidelines for major medical devices and new-tech equipments. A guide for formulating technical documents to improve local quality management and international competitiveness
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of medical devices was also published. Likewise, they published journals of guidelines on the recommended amounts of radiation for patients and an individual, to reduce patients and health industry laborers exposure to radiation.
reviewed for the general management and real condition of management within it.
3) Future Plans
The NIFDS will develop a new technique for the safety evaluation of newly introduced medical devices and new growth engine industries based on the development of scientific technology. The institute will regularly develop and implement standards for various medical equipments. In addition, it will prepare an integrated management system for external diagnostic products, which are currently being managed separately as medicine and medical devices domestically, and publish manuals and check-list for long-term enhancement of GMP. Finally, it will develop and secure an evaluation technique of radiation for safety management in treatment and diagnostic fields, and publish guidelines by regularly providing relevant information.
(7) T esting of Medical Device Quality Management and Supporting Inspections of Testing Institutions
The testing of medical device secured the reliability and fairness on test results through the establishment of scientific and advanced test methods. The KFDA performed technical support for the designation of test institution and evaluated/
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consultations on regulatory issues ranging from the initial drug development stage through final approval processes, and provide clients with opportunities to receive the necessary training regarding regulatory matters related to drug approval.
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1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. I mprovement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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mprovement of Status of the Institute as an I International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique
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2007 and product information DB in 2008, to support the professional treatment of poisoning in regional areas. The current toxicity information system, known as ToxInfo, merged all three systems mentioned above into one database.
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(2) S tudy on the Identification of Toxicity Indicator for Living Body Using Biological Information Science
The NIFDS is to develop LiverToxPredictor program, which can identify both known and unknown liver toxins and their interrelations, and toxicity prediction indicators. This program will be provided to the KOTIS database (http://kotis.NIFDS.go.kr).
2) Pharmacosafety Research
The NIFDS developed various types of training resources, such as the guide and leaflets on testing procedures for pharmaco-safety, to support new drug developers. It also hosted the 12th Pharmacology Research and Pharmacosafety Seminiar, to play a leading role in the exchange of relevant technologies in this field.
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3) Dependence Study
The NIFDS performed evaluation tests for dependence and examination propofol and its abuse, to provided clear scientific basis in defining it as a psychotropic drug for the first time in the world. The institute also published and distributed a pamphlet titled Beware the use of Propofol!, and produced the 8th Scientific Information paper on Drug (SIDA) containing an article on propofol to prevent its abuse.
conditions for drug usages for Koreans are particularly relevant. Department of clinical study of NIFDS, which hosted a symposium for leading researcher consultative group of pharmacogenomics, is developing a diagnostic kit for Korean pharmacogenomic type and currently possess 11 patents for various pharmacogenomic types. The institute also maintains a Korean pharmacogenomic information DB on the NIFDS website. It established a basis of development and evaluation for personalized drugs appropriate to the Korean pharmacogenomic type. In 2010, this study was selected as one of the 100 leading national researches and development programs.
2) Study on the Establishment of an Evaluation Basis on Clinical Trials for Korean Population
A clinical trial is a test or research performed on humans to identify movement, history, action, clinical effect of a drug. The trial also investigates abnormal reactions of the drug to confirm their safety and efficacy of a drug. In a development process, a clinical trial is a highly significant step in deciding the effectiveness, and usage-volume of medicine because safety management, including quality, safety and efficacy of medicine, is necessary. The department of clinical study is establishing Microdose Clinical Trial Guideline,
which fits domestic situation, to address the international vitalizations of microdose clinical trial, a high tech clinical trial technique that can increase the success rate in the development of a new drug. The institute has also hosted a Workshop for using Initial Stage of Clinical Trial (phase 0) in Developing New Drugs. It also established Clinical Trial Database to ensure evaluation technique of clinical trial and are preparing to upload data of nearly 1,000 clinical trials.
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1. Building Advanced Foundation for Scientific Risk Assessment 2. Enhancement of Status as an International Institute for Test Analysis and Research 3. Providing Scientific Basis for Advanced License Screen System and Safety Management 4. Improvement of Status of the Institute as an International Safety Evaluation Institution through the Enhancement of Safety Evaluation Technique 5. Upgrading National Prestige through Enhancing International Cooperation
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through training workshops. The AHC is working continuously to provide practical and useful training programs for regulators and industry experts in the APEC region, thus contributing to bringing
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growth in regional efforts to achieve regulatory harmonization of pharmaceuticals and medical devices. The AHC has so far been highly regarded for its excellent training programs. The AHC will continue to work hard to meet the training needs of the region and become an exemplary model for regulatory harmonization in the region.
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training on a vaccine to WHO. The KFDA underwent a clinical trial examiner training to operate WHO Global Learning Opportunities (GLO) and was authorized to become a WHO GLO clinical trial (GCP) training center. The KFDA will secure professionalism of GMP inspector, and establish a scientific and efficient approval/evaluation system by cooperating with WHO to become an international leading regulatory body.
The KFDA has performed various WHO collaborating activities such as joint research on international standard products, provision of GMP inspector training and similar works from 1998 up to the present. Table 7-5-1 Major Programs of WHO Collaborating Activities (Aug. 1998~Jul. 2011 up to the Present)
Field International joint research Main Contents Establishment of international standard of endotoxin, Establishment of international standard of BCG vaccine and etc. Training for GMP inspectors from 14 countries such as Thailand and Egypt, selected by WHO Evaluation on stability of vaccine, regulation on biological medicine and etc. WHO Assessment Guideline for biopharmaceuticals and etc. Expert meeting on WHO biopharmaceutical regulation, Network meeting on vaccine regulation, etc.. Performances 23 6 4 5 56
Training Hosting WHO/KFDA Joint workshop Support for development of WHO guideline Participation of international meeting
The KFDA will perform technical reviews on newly established or revised WHO guidelines, international joint researches as a WHO collaborating center, and will host workshops for the application of international standards in WHO Western Pacific Regional Office (WPRO).
WHO divided and administered the entire world in 6 regions, with South Korea included within the West Pacific region
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The EDQM is a specialized institution which conducts researches that can serve as a basis of safety management such as the publishing and distribution of European Pharmacopoeia, validation of test and analysis for the contents of standard in Pharmacopoeia, management and distribution of standard products of drugs and biological drugs. They agreed to exchange information on the standard of pharmacopoeia, technical cooperation on the standard products of drugs and biological drugs, technical cooperation and exchange of information between tests and analysis laboratories (such as OMCL), mutual training of workers and hosting of the joint workshop.
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