China
China Pharmaceutical Regulatory Report 2009
| Publication Date | January 2009 |
| Publisher | Pacific Bridge Medical |
| Product Type | Report |
| Pages | 56 |
| ISBN Number | not applicable |
| Product Code | PBM00004 |
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Summary
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 recent overhaul of China's drug regulations. It also contains the annexes to this document detailing dossier submission requirements, all up-to-date.
Fully updated for 2009, with new information on several key topics including combination drug-device products and biological products.
Contents
- I. China Pharmaceutical Industry Overview
- A. Overview
- B. China Pharmaceutical Market Trends
- C. Brief Overview of China's Pharmaceutical Regulations
- D. 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
- F. New Drug Registration Process
- G. OTC New Drug Registration Process
- H. New Drug Registration Statistics
- I. Classification of Combination Drug-Device Products
- 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
- F. Biological Products
- 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
- H. Drug Recalls
- 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
- Healthcare statistics in Asia (charts)
