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China Regulatory and Market Access Pharmaceutical Report (2013)

NEW YORK, April 15, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

China Regulatory and Market Access Pharmaceutical Report (2013)

China Regulatory and Market Access Pharmaceutical Report (2013)

China's pharmaceutical market is booming! The market is growing almost 15% annually and is expected to be about $100 billion dollars in 2017. This brand new report covers the best way to register your drug there and optimize market access to increase sales in China.

Drug regulations are complicated in China. This report discusses clinical trials, required drug documentation for approval, GCP, GMP, etc.

Once your drug is approved, what needs to be done to sell it in China? This report also covers issues like drug pricing, reimbursement, provincial bidding, hospital tenders, etc.

This report includes 17 appendices. They include application forms for pharmaceutical products, a list of Chinese CROs, the essential and national reimbursement drug lists, etc.

Pages: 282 (Including 98 pages of the basic report and 184 pages in the 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. China Food and Drug Administration (CFDA)

II. The China Healthcare System

A. History of China's Healthcare System
B. Struggling Healthcare Services Sector
C. 2009 Healthcare Reform
D. Hospitals and Medical Resources
1. Hospitals in China
2. Current Problems in the Hospital Sector
3. Private Investment in the Hospital Sector
4. Hospital Reform
E. Health Insurance in China

III. Drug Registration Regulations

A. Drug Registration Policy
B. Classification of Drugs
C. Drug Registration Applications
D. Application Documents for New Drug Registration
E. Technical Review Guidance for Registration Documents
F. New Drug Registration Process
G. Clinical Trials
H. Timeframe to get an Imported Drug Approved
I. OTC New Drug Registration Process
J. Drug Registration Re-Examination
K. Drug Registration Statistics
L. Classification of Combination Drug-Device Products
M. New Regulatory Changes

IV. Drug Pricing Regulations

A. Overview of Drug Pricing Policy
B. Controls on Drug Pricing
C. Reimbursement Drug Lists
D. NRDL and PRDL Pricing
E. Bidding and Hospital Listing

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. Good Manufacturing Practice (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
1. Current Developments in Drug Distribution
2. Drug Distribution Policy
3. Renewal of Drug Distribution Licenses
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. Setting Up your Business in China

XII. What Other Companies are Doing in China

A. Joint Ventures (JV)
B. Acquisitions
C. Licensing

XIII. Conclusion


1. Application Form for Pharmaceutical Products
2. Listing of CROs in China
3. Regulatory Specifics for Clinical Trials in China
4. Administrative Provisions for Drug Registration (translated law)
5. Registration for TCM (translated law)
6. Registration for Chemical Drugs (translated law)
7. Registration for Biological Drugs (translated law)
8. Supplemental Drug Application Registration (translated law)
9. Drug Re-Registration Application (translated law)
10. Drug Monitoring Periods
11. Application and Approval Procedures and Timeline for Imported Drugs
12. Application and Approval Procedures and Timeline for Clinical Trials
13. Listing of CFDA-affiliated organizations in China
14. Healthcare Statistics and Pharmaceutical Markets in Asia (charts)
15. The National Essential Drug List (2013): Chemical and Biological Drugs
16. The National Essential Drug List (2009): Chemical and Biological Drugs
17. National Reimbursement Drug List (2009): Western Medicines

To order this report:
China Regulatory and Market Access Pharmaceutical Report (2013)

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