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The China Pharmaceutical Market: A Strategic Opportunity Analysis

Published by: Pharmalicensing Ltd.

Published: Jan. 1, 2007 - 100 Pages



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

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


Abstract

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. 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.

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