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1/15/2009 China Pharmaceutical Regulatory Rep…

Pacific Bridge Medical - China Medical Publications

China Pharmaceutical Regulatory Report 2008

Published by Pacific Bridge Medical Print Article


By Ames Gross and John Minot April 2008

Price: $750

Price: $1500

Overview:

This report includes a brief overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the
relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of
pharmaceutical products. Specific topics include: product registration, pricing and reimbursement, importation, GMP, GCP,
orphan drugs, and intellectual property protection.

This report's appendix contains a full translation of the revised Administrative Provisions for Drug Registration, the overhauling
of China's drug regulations that just came into effect on October 1, 2007. It also contains the annexes to this document
detailing dossier submission requirements, all up-to-date.

You can purchase the 53-page report for $750. For $1500, you can purchase the report plus the 125-page appendix including
translations of key pharmaceutical regulations, pharmaceutical statistics, registration forms, China CRO contacts, and a
timeline for the pharmaceutical registration process.

Fully updated for 2008.

Click here to view a sample page of this report.

Click here to view a sample page of this appendix.

Table of Contents:

I. China Pharmaceutical Industry Overview


A. Overview
B. Brief Overview of China's Pharmaceutical Regulations
C. The State Food and Drug Administration

II. The China Healthcare System


A. History of Healthcare System in China
B. Struggling Healthcare Services Sector
C. Hospitals and Medical Resources
D. Health Insurance in China

III. Drug Registration Regulations


A. Drug Registration Policy
B. Classification of Drugs
C. Drug Registration Application
D. Application Documents for New Drug Registration
E. Technical Review Guidance for Registration Documents

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1/15/2009 China Pharmaceutical Regulatory Rep…
F. New Drug Registration Process
G. OTC New Drug Registration Process

IV. Drug Pricing Regulations


A. Overview of Drug Pricing
B. Controls on Drug Pricing
C. National Essential Medical Insurance Drug List

V. Pharmaceutical Research and Development and Related Regulations


A. China's Research and Development Climate
B. Clinical Research
C. Good Clinical Practice (GCP)
D. GCP-Certified Clinical Research Centers
E. Good Laboratory Practice (GLP)
F. Adverse Event Reporting Requirements

VI. Pharmaceutical Manufacturing Regulations


A. Manufacturing Pharmaceuticals in China
B. GMP Regulations
C. GMP Certification
D. Drug Manufacturing Administration
E. Drug Manufacturing Certificate

VII. Selling Pharmaceuticals and Related Regulations


A. WTO Agreement on Drug Sales
B. Drug Sales to Hospitals
C. Selling Drugs in Drug Stores
D. Drug Sales on the Internet
E. Distribution Regulations
F. OTC Drug Sales
G. Regulations on Drug Imports

VIII. Marketing Drugs in China


A. Packaging Requirements

IX. Drug Advertising

X. Intellectual Property Protection


A. Current Intellectual Property Situation in China Pharmaceutical Market
B. Examples of Pharmaceutical Companies Experience with IPR infringement in China
C. Administration Protection (AP)

XI. Conclusion

APPENDICES:

Application Form for Drug Registration


Listing of CROs in China; Regulatory Specifics for Clinical Trials in China
Administrative Provisions for Drug Registration (translated law)
Registration for TCM (translated law)
Registration for Chemical Drugs (translated law)
Registration for Biological Drugs (translated law)
Supplemental Drug Application Registration (translated law)
Drug Re-registration Application (translated law)
Drug Monitoring Periods
Application and Approval Procedures and Timeline for Imported Drugs
Application and Approval Procedures and Timeline for Clinical Trials
Listing of SFDA-affiliated organizations in China

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Healthcare statistics in Asia (charts)

Order now and we will ship you this report at NO ADDITIONAL CHARGE.

Price:
$750 Report only
$1500 Report + Appendix

Contact us at researchstore@pacificbridgemedical.com if you have any questions.

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