Abstract
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 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.
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
- 4.2. 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
