China Pharmaceutical Regulatory Report 2011 + Appendix

Pacific Bridge Medical, January 2011, Pages: 203

This regulatory report includes an overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the relevant Chinese laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of pharmaceutical products. Specific topics for drug companies 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 recent overhaul of China's drug regulations. It also contains the annexes to this document detailing dossier submission requirements. These will help drug companies in their product registration process in China.

The 74-page report with 129-page appendix including translations of key pharmaceutical regulations, pharmaceutical statistics, registration forms, China CRO contacts, and a timeline for the pharmaceutical registration process.

Updates for 2011 include:

- Latest healthcare developments in China and their impact on foreign drug companies
- China’s new healthcare reform policies and its impact on pharmaceutical regulations
- New Chinese pharmaceutical regulations and updated policies on drug manufacturing (GMP), distribution and clinical research in China
- An expanded and revised list of Clinical Research Organizations in China for outsourcing by foreign drug companies (Appendix)

I. China Pharmaceutical Industry Overview
A. Overview
B. China Pharmaceutical Market Trends
C. China’s Pharmaceutical Distribution System
D. Brief Overview of China's Pharmaceutical Regulations
E. The State Food and Drug Administration

II. The China Healthcare System
A. History of China’s Healthcare System
B. Struggling Healthcare Services Sector
C. 2009 Healthcare Reform
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
F. New Drug Registration Process
G. OTC New Drug Registration Process
H. Drug Registration Re-examination
I. Drug Registration Statistics
J. Classification of Combination Drug-Device Products
K. New Regulatory Changes

IV. Drug Pricing Regulations
A. Overview of Drug Pricing
B. Controls on Drug Pricing
C. National Reimbursement 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. Overview of Manufacturing in China
B. GMP Regulations
C. GMP Certification
D. Drug Manufacturing Administration
E. Drug Manufacturing Certificate
F. Biological Products

VII. Selling Pharmaceuticals and Related Regulations
A. WTO Agreement on Drug Sales
B. Drug Sales to Hospitals
C. Drug Purchasing System
D. Selling Drugs in Drug Stores
E. Internet Drug Sales
F. Distribution Regulations
G. OTC Drug Sales
H. Regulations on Importing Drugs
I. Drug Recalls
J. Drug Safety
K. Authorized Quality Person

VIII. Marketing Drugs in China and Related Regulations
A. Packaging Requirements

IX. Drug Advertising Regulations

X. Intellectual Property Protection and Patents
A. Intellectual Property in the China Pharmaceutical Market
B. Pharmaceutical Companies Experiencing IPR Problems
C. Administrative 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
- Healthcare statistics and pharmaceutical markets in Asia (charts)

Also available

• China Pharmaceutical Regulatory Report 2011

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