The Chinese Pharmaceutical Market: A strategic opportunity analysis

Table of Contents

1. Introduction

2. The Chinese healthcare system

• 2.1. A historical perspective
• 2.2. China' s healthcare system: Reforms
  • 2.2.1. The basic trend of the system reform: Commercialization and market orientation
  • 2.2.2. Achievements in health system reform
  • 2.2.3. Defects in the design of the new rural cooperative medical system

3. The Chinese pharmaceutical industry

• 3.1. History
• 3.2. Industry growth
• 3.3. Pharmaceutical trade (exports and imports)
• 3.4. The pharmaceutical distribution structure in China
• 3.5. Traditional Chinese medicine
  • 3.5.1. Modernization of Chinese medicine
  • 3.5.2. Drawbacks of TCM
  • 3.5.3. TCM worldwide

4. Driving forces behind the Chinese pharmaceutical market

• 4.1. Issues and opportunities in the pharmaceutical market
  • 4.1.1. SWOT analysis
• 4.2. Effect of the Chinese macro-environment on the pharmaceutical industry: A PEST analysis
  • 4.2.1. Political
  • 4.2.2. Economic
  • 4.2.3. Sociological
  • 4.2.4. Technological
  • 4.2.5. The urban-rural divide
  • 4.2.6. Steep market growth
  • 4.2.7. First-class biopharmaceutical institutions
  • 4.2.8. Good manufacturing practices
  • 4.2.9. Huge market potential
  • 4.2.10. Strong support from the Government
  • 4.2.11. Expansion into rural areas
  • 4.2.12. Social culture
  • 4.2.13. The trend toward self-medication

5. Health insurance in China

• 5.1. Government insurance
  • 5.1.1. The rural health protection system
  • 5.1.2. The urban health protection system
• 5.2. Commercial medical insurance in China
• 5.3. Health insurance take-up in China

6. Regulatory environment

• 6.1. Chinese pharmaceutical regulations: A historical perspective
• 6.2. Brief developmental history
• 6.3. Drug regulatory structure and functions
  • 6.3.1. Ministry of Public Health
  • 6.3.2. State Economic Trade Commission
• 6.4. State Food and Drug Administration
  • 6.4.1. New regulations on drug importation
• 6.5. Responsibilities of the SFDA
• 6.6. The registration process- medical devices
  • 6.6.1. Document preparation (stage one)
    • 6.6.1.1. SFDA registration form
    • 6.6.1.2. Legal production qualification
    • 6.6.1.3. Business license for the Chinese agent registering the product
    • 6.6.1.4. Marketing approval from the country of origin
    • 6.6.1.5. Product standards
    • 6.6.1.6. Operation or user manual
    • 6.6.1.7. Test report
    • 6.6.1.8. Clinical trial report
    • 6.6.1.9. Quality guarantee letter
    • 6.6.1.10. Agent authorization letter
    • 6.6.1.11. After-sales authorization
    • 6.6.1.12. Self-guarantee declaration
  • 6.6.2. Type testing and clinical trials (stage two)
    • 6.6.2.1. Type testing
    • 6.6.2.2. Clinical trials
  • 6.6.3. Registration submission (stage three)
  • 6.6.4. Issuance of the registration certificate (stage four)
  • 6.6.5. Registration procedure
  • 6.6.6. China Compulsory Certificate
• 6.7. The registration process- pharmaceuticals
• 6.8. A few practical points regarding the management of SFDA registration
  • 6.8.1. Complicated process
  • 6.8.2. Lengthy process
  • 6.8.3. Consultant support
  • 6.8.4. Product packaging compliance

7. Legal reform: IPR

• 7.1. Patent protection
  • 7.1.1. China' s accession into the WTO
  • 7.1.2. Impact of IPR and regulatory changes
  • 7.1.3. Impact on the industry

8. Research and development in China

• 8.1. Domestic R&D