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The China Pharmaceutical Market: A Strategic Opportunity Analysis
Pharmalicensing Ltd., Jan 2007, Pages: 100
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
Siraj Dhanani, Phrmacist, MS (Mktg), MBA (NYU), Chief Executive Officer, PharmARC
Amit Sadana, MS (Statistics; NJIT/Rutgers), President, PharmARC
Ashish Malik, MS (Biotechnology), MBA (Mktg), Senior Client Manager, PharmARC
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