China Regulatory and Market Access Pharmaceutical Report 2014

China’s pharmaceutical market is booming! The market is growing almost 15% annually and is expected to be about $100 billion dollars in 2017. However, drug regulations are complicated in China. In addition, once your drug is approved, what needs to be done to sell it in the Chinese market? This report covers the best way to register your drug there and optimize market access to increase sales in China. Topics that will be discussed include clinical trials, required drug documentation for approval, GCP, GMP, drug pricing, reimbursement, provincial bidding, hospital tenders, and more.

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Table of Contents:

1. China Pharmaceutical Industry Overview
   1. Overview
   2. China Pharmaceutical Market Trends
   3. China’s Pharmaceutical Distribution System
   4. Brief Overview of China’s Pharmaceutical Regulations
   5. China Food and Drug Administration (CFDA)
2. The China Healthcare System
   1. History of China’s Healthcare System
   2. Struggling Healthcare Services Sector
   3. 2009 Healthcare Reform
   4. 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
   5. Health Insurance in China
3. Drug Registration Regulations
   1. Drug Registration Policy
   2. Classification of Drugs
   3. Drug Registration Applications
   4. Application Documents for New Drug Registration
   5. Technical Review Guidance for Registration Documents
   6. New Drug Registration Process
   7. Clinical Trials
   8. Timeframe to get an Imported Drug Approved
   9. OTC New Drug Registration Process
   10. Drug Registration Re-Examination
   11. Drug Registration Statistics
   12. Classification of Combination Drug-Device Products
   13. New Regulatory Changes
4. Drug Pricing Regulations
   1. Overview of Drug Pricing Policy
   2. Controls on Drug Pricing
   3. Reimbursement Drug Lists
   4. NRDL and PRDL Pricing
   5. Bidding and Hospital Listing
5. Pharmaceutical Research and Development and Related Regulations
   1. China’s Research and Development Climate
   2. Clinical Research
   3. Good Clinical Practice (GCP)
   4. GCP-Certified Clinical Research Centers
   5. Good Laboratory Practice (GLP)
   6. Adverse Event Reporting Requirements
6. Pharmaceutical Manufacturing Regulations
   1. Overview of Manufacturing in China
   2. Good Manufacturing Practice (GMP) Regulations
   3. GMP Certification
   4. Drug Manufacturing Administration
   5. Drug Manufacturing Certificate
   6. Biological Products
7. Selling Pharmaceuticals and Related Regulations
   1. WTO Agreement on Drug Sales
   2. Drug Sales to Hospitals
   3. Drug Purchasing System
   4. Selling Drugs in Drug Stores
   5. Internet Drug Sales
   6. Distribution Regulations
      1. Current Developments in Drug Distribution
      2. Drug Distribution Policy
      3. Renewal of Drug Distribution Licenses
   7. OTC Drug Sales
   8. Regulations on Importing Drugs
   9. Drug Recalls
   10. Drug Safety
   11. Authorized Quality Person
8. Marketing Drugs in China and Related Regulations
   1. Packaging Requirements
9. Drug Advertising Regulations
10. Intellectual Property Protection and Patents
    1. Intellectual Property in the China Pharmaceutical Market
    2. Pharmaceutical Companies Experiencing IPR Problems
    3. Administrative Protection (AP)
11. Setting Up your Business in China
12. What Other Companies are Doing in China
    1. Joint Ventures (JV)
    2. Acquisitions
    3. Licensing
13. Conclusion