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The China Pharmaceutical Market: A Strategic Opportunity Analysis


Publication Date   January 2007
Publisher   Pharmalicensing
Product Type   Report
Pages   100
ISBN Number   not applicable
Product Code   PHM005
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Price £600.00

approximately: $1,121 | €761

Summary


China has become an attractive destination for R&D as new opportunities have emerged following its WTO (World Trade Organization) accession. Development has accelerated both industrially and scientifically, and today the Chinese pharmaceutical market is worth around $US12 billion.

Factors fuelling the developmental growth and attracting foreign investors to the area include low labor costs, high quality clinical data and an abundance of R&D collaborative opportunities and facilities.
Global biotechnology within China has also undergone significant growth, promising enormous potential for new companies. Biotechnology companies in the country have already grown quicker than pharmaceutical companies.

The report discusses the whole of the Chinese pharmaceutical market, taking readers through the history and current state of the healthcare system through to the regulations governing the country and its growing R&D capabilities. Detailing the driving forces behind the pharma market and including a full breakdown of the biopharma opportunities, including the contacts of active Chinese companies, the report is an essential resource to understand and access this lucrative market.

Reasons to purchase this report:
  • Identify key partners
  • Assess the current market opportunity
  • Learn how newly implemented government changes have altered the face of the industry
  • Understand the organization and success of clinical trials in China
  • Create strategies for profitable market access into China
The Chinese government also plays an instrumental role in the pharmaceutical development of China. The introduction of WTO guidelines and protection for intellectual property rights has caused a shift in the company structures of China, forcing some to close business or enter into new collaborations.

Ideally suited for individuals wishing to introduce their companies into this emerging market or review the opportunities available, this report provides a perfect resource to identify the current pattern of the market and understand the regulations that operate within the country.

Content


  • 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
    • 8.2 Collaborations with China
      • 8.2.1 Why China?
        • 8.2.1.1 Attractive tax incentives
        • 8.2.1.2 Increasing R&D expenditure
      • 8.2.2 Non-Chinese companies partnering in China
    • 8.3 Non-Chinese companies performing R&D in China
  • 9. Clinical investigation in China
    • 9.1 Key drivers for rapid increase in number of global trials being conducted in China
      • 9.1.1 Rapid patient recruitment
      • 9.1.2 Quality
      • 9.1.3 Future marketing in China
      • 9.1.4 Acceptance of data by FDA
      • 9.1.5 Regulatory requirements
      • 9.1.6 Non-Chinese companies conducting trials in China
  • 10. Chinese vaccine market
  • 11. Conclusion
  • 12. China: Emerging biopharma opportunities
    • 12.1 Collaborative opportunities in life science R&D in China
      • 12.1.1 Contract discovery research and clinical development (biologics and small molecules) companies
        • 12.1.1.1 Shanghai ChemPartner
        • 12.1.1.2 Shanghai BioExplorer
        • 12.1.1.3 WuXi PharmaTech
        • 12.1.1.4 Vivo Development
      • 12.1.2 Companies engaged in NCE research for global licensing
        • 12.1.2.1 FusoGen Pharmaceuticals
        • 12.1.2.2 Hutchison MediPharma
        • 12.1.2.3 StarVax International
        • 12.1.2.4 Shanghai Kairun Pharmaceuticals
      • 12.1.3 Academic and research institutes offering collaborative R&D opportunities
        • 12.1.3.1 Shanghai Institute of Materia Medica, Chinese Academy of Sciences
        • 12.1.3.3 Guangzhou Institute of Biomedicine and Health
        • 12.1.3.4 Shanghai Institutes of Biological Sciences
      • 12.1.4 Primate research centers for biologics or drug testing
        • 12.1.4.1 Kunming Primate Research Center, Chinese Academy of Sciences
        • 12.1.4.2 Facilities and resources
        • 12.1.4.3 Gaoyao Kangda Animal Research Center
  • 13. Appendices
    • 13.1 References
    • 13.2 Resources
    • 13.3 Abbreviations
    • 13.4 Glossary
    • 13.5 Author biographies