Abstract
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 recent overhaul of
China' s drug regulations. It also contains the annexes to this document
detailing dossier submission requirements, all up-to-date.
You can purchase this 70-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 2010!
Completely new information has been added to this report, including
distribution in Section I, the 2009 Health Care Reform in Section II, new
regulatory changes in Section III, drug purchasing system in Section VII, and
drug safety in Section VIII. There are also updates on drug registration
statistics, GMP, re-registration processes, and packing requirements. The
appendix has also been updated, such as CRO information and SFDA affiliate
organizations.
Table of Contents
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 Healthcare System in China
- B. Struggling Healthcare Services Sector
- C. Hospitals and Medical Resources
- D. Health Insurance in China
- E. 2009 Health Care Reform
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
- J. New Regulatory Changes
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. Drug Purchasing System
- D. Selling Drugs in Drug Stores
- E. Drug Sales on the Internet
- F. Distribution Regulations
- G. OTC Drug Sales
- H. Regulations on Drug Imports
- I. Drug Recalls
VIII. Drug Safety
IX. Authorized Quality Person
X. Marketing Drugs in China
- A. Packaging Requirements
XI. Drug Advertising
XII. 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)
XIII. Conclusion
APPENDICES:
- A. Application Form for Drug Registration
- B. Listing of CROs in China; Regulatory Specifics for Clinical
Trials in China
- C. Administrative Provisions for Drug Registration (translated law)
- D. Registration for TCM (translated law)
- E. Registration for Chemical Drugs (translated law)
- F. Registration for Biological Drugs (translated law)
- G. Supplemental Drug Application Registration (translated law)
- H. Drug Re-registration Application (translated law)
- I. Drug Monitoring Periods
- J. Application and Approval Procedures and Timeline for Imported
Drugs
- K. Application and Approval Procedures and Timeline for Clinical
Trials
- L. Listing of SFDA-affiliated organizations in China
- M. Healthcare statistics in Asia (charts)
