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Published by: Urch Publishing
Published: Jun. 1, 2000 - 206 Pages
Table of Contents
EXECUTIVE SUMMARY
PREFACE
1: CHINA'S DRUG ADMINISTRATION SYSTEM
- Past and present of China's drug administration
- History
- Development of the PRC's drug administration institutions
- Establishment of the State Drug Administration
- Function and structure of the State Drug Administration
- Major functions of the State Drug Administration
- Structure of the State Drug Administration
- New features of the State Drug Administration
- Current objectives and tasks for national drug administration
- Technical support departments of the national drug administration system
- State Pharmacopoeia Committee
- National Institute for the Control of Pharmaceutical and Biological Products
- National Committee for TCM Protection and Evaluation
- SDA Drug Review Centre
- SDA Medical Device Products Review and Registration Centre
- SDA Drug Evaluation Centre
- SDA Drug Accreditation Centre
- Establishment of the local drug administration system
- Principles for the establishment of the local drug administration system
- Progress in the reorganisation of the local drug supervision agencies
2: DRUG ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
- Legislation on drug administration
- Significance of the Drug Administration Law
- The 1999 amendment of the Drug Administration Law
- Outline of the 1999 Drug Administration Law
- Approval and registration of drugs
- Definitions
- New drugs and the application and approval for production
- Application and approval for imported drugs
- Drug standard
- Licensing system and administration of drug production and sales
- Major features of the licensing system
- Definitions
- Provisions on drug production and sales
- Provisions on traditional Chinese medicine
- Principles of TCM regulation
- Different provisions for TCM as against other types of drugs
- Legal liabilities provided in the Drug Administration Law
- Breach of law and legal liabilities
- Legal liabilities for producing and selling adulterated and inferior drugs
- Legal liabilities for unlicensed production or sales of drugs
- Legal liabilities for violating other provisions in the drug production and sales administration
- Legal liabilities for violation of law by drug administration employees in service
3: ADMINISTRATION OF DRUG REGISTRATION
- Administration of approval of new drugs
- Definition and scope of new drugs
- Classification of new drugs
- Preclinical investigation of a new drug
- Clinical investigation of new drugs
- Application and approval of new drugs
- Information and data needed for new drug applications
- Approval of new drugs
- Trial production of new drugs
- Quality standards for new drugs
- Supplementary applications for new drugs
- Protection of new drugs
- Technology transfer of new drugs
- Inspection and approval of generic drugs
- Definition of generic drugs
- Conditions and requirements of application for registration
- Application and approval procedures for registration
- Documents to be submitted in application for generic drugs
- Registration and administration of imported drugs
- Definition and administrative scope of imported drugs
- Basic requirements for imported drugs
- Registration procedures
- Basic requirements for registration applicants
- Principles of rejection of registration
- List of documents to be submitted for registration of imported drugs
- Quality revalidation of imported drugs
- Clinical investigation
- Approval and issuing of registration for imported drugs
- Renewal of the Registration Certificate of Import Drugs
- Supplementary applications for imported drugs
- Revalidation of imported drugs
- Examination of imported drugs
- Penalties in administration of imported drugs
4: SUPERVISION, ADMINISTRATION AND RE-EVALUATION OF DRUG RESEARCH AND PRODUCTION
- Supervision and administration of drug research
- Registration of drug research institutions
- Application of the GLP accreditation system
- Adoption of the GCP accreditation system and establishment of bases for clinical drug research
- Punishment for violations of legislation and regulations
- Monitoring of pharmaceutical production
- Administration of licences issued for pharmaceutical manufacturers
- Administration on licences for self-prepared medication of medical institutions
- Good Manufacturing Practice (GMP)
- Administration of drug classification and the National
- Basic Drug List system
- Significance and basic principles of administration of drug classification
- Outline of drug classifications
- Plan and objectives of drug classification
- System of National Basic Drugs
- Adverse reactions and post-market re-evaluation of drugs
- Administration of drugs for special uses
5: SUPERVISION AND ADMINISTRATION OF DRUG DISTRIBUTION
- Laws and regulations of drug distribution
- Administrative measures in drug distribution
- Administrative penalty procedures in drug supervision
- Regulations forbidding medical enterprises from attracting non-medical enterprises into the
business
- Regulations forbidding cross-province or cross-city subsidiary hospitals from using prepared drugs from their main hospital
- Regulations forbidding medicine markets to open
- Regulations forbidding individuals from entering into contracts with medical businesses or enterprises
- Disposal of drugs in bankrupt enterprises
- Qualification authentication of drug wholesalers and retailers
- 'Qualification Authentication of Newly Opened Medical Enterprises'
- 'Detailed Rules of Wholesale Business Qualification Assessment'
- Quality management in medical business
- Good Sales Practice (GSP)
- GSP authentication management
- Detailed articles of GSP authentication
- The Licence to Run Medical Businesses
- Administration of the Licence to Run Medical Businesses
- Qualification standard for the renewal of the Licence to Run Medical Businesses
- Medicine Quality Control and the National Medicine
- Quality Bulletin
- Basic structure of the medicine quality control system
- Production of the National Medicine Quality Bulletin
- Penalties for unqualified medicines on the National Medicine Quality Bulletin
- Penalties on counterfeit and poor-quality medicine
- Procedures of investigation and penalties for counterfeit and poor-quality medicine
- Responsibilities and divisions of administrative penalty work on counterfeit and poor-quality
medicines
- Supervision of TCM material markets
- Penalties for counterfeit and poor-quality medicines in TCM material markets
- Examination and administration on medicine advertisements
- Advertisement Law of the People's Republic of China
- Measurements of advertisement examination
- Guidelines for medicine advertisement examinations
- Other regulations related to medicine advertisement administration and examination
6: ADMINISTRATION OF THE MEDICAL SYSTEM IN CHINA
- Reform of the Medical Administration System and transformation of its functions
- Function of the Medical Department under the State
- Economic and Trade Commission
- General Affairs Section (or the Enterprise and Institution Reform Section)
- Planning and Development Section
- Trade Administration Section
- Administrative functions delegated to national trade societies and associations
- National medical trade societies and associations
- Administrative work delegated to trade associations and societies
- Reforms on and requirements for function allocation of local medical administration
- Outline of 'the Ninth 5-year Plan' for the pharmaceutical industry
- Major economic targets in 'the Ninth 5-Year Plan' for the pharmaceutical industry
- Phases to reach the economic targets set in 'the Ninth 5-Year Plan' for the pharmaceutical industry
- Major development areas in 'the Ninth 5-Year Plan'
- Foreign investment guidance in the medical industry
- Fundamental policies for foreign investment in the pharmaceutical industry
- Foreign investment guidance in the medical industry
7: ADMINISTRATION OF THE PRICE OF MEDICAL PRODUCTS IN CHINA
- Organisation of price administration on medical products at state level
- State Development Planning Commission
- Principles of government fixed price and guide price of medical products
- Formulation of central government fixed price and guide price lists
- Principles in pricing and price adjustment
- Principles for government guide price and government fixed price
- Principles in pricing and price adjustment
- Principles in the pricing of imported drugs
- Measures taken in the pricing and price adjustment of drugs
- Manufacturer's prices of various drugs (TCM materials and herbal decoctions excluded)
- Prices fixed by enterprises
- Principles for the market-adjusted pricing of drugs
- Principles for the pricing of other drugs
- Discount rate for sales of drugs
- Registration of drug sales
8: REFORMS TO THE HEALTHCARE SYSTEM IN CHINA AND THEIR IMPACT ON THE PHARMACEUTICAL MARKET
- Public Medical Care and Labour Healthcare Systems
- Positive contributions and impact on the pharmaceutical market
- Main problems
- Reforms of the medical care system
- Pilot studies at the 'Two Cities'
- 'Reforms' extended to 57 cities
- Range of reimbursable medicines covered by the Public Medical Care System
- Capping the total expenditure and adjusting its composition
- Pilot study boosting over-the-counter (OTC) sales
- Basic Health Insurance System for employees in cities and townships
- Importance of health insurance as part of the social security system
- Main features in the Basic Health Insurance System for employees in cities and townships
- Wide coverage and basic standard
- Raising and use of funds
- Drug list of the Basic Health Insurance System for employees in cities and townships
- Independent accounting and administration of drugs and medical services
- Co-operative Healthcare System in rural areas
- Rural areas: the focus of healthcare policies of the Chinese government
- Co-operative Healthcare System
- Establishment of healthcare organisations and healthcare personnel teams in rural areas
- Higher expectations of wellbeing in the countryside
- Countryside - a new growth area in the Chinese medical economy
- Objectives for healthcare reform and development
- Objectives for healthcare development in China
- Healthcare in China has a long way to go
9: DEVELOPMENT OF THE MEDICAL INDUSTRY IN CHINA
- Development of the pharmaceutical industry
- Scope and overview of the pharmaceutical industry
- Synthetic pharmaceutical industry
- Traditional Chinese medicine industry
- Development of the medicine business
- Distribution model for medicines
- China's medicine market
- Prospect of China's medicine market
- Intellectual property rights of medicines and development of new medicines
- Development and perfection of protecting intellectual property rights of medicines
- Research and exploitation of new medicines shifting from imitation to innovation
- Development of medical education
- Higher medical education
- Secondary medical education
- Continuous education in the medicine trade
- Emergence and continuation of post-training of employees in the medicine trade
APPENDICES
LIST OF TABLES
- Table 3.1: Data requirements for application for clinical investigation of new drugs (synthetic)
- Table 3.2: Data requiremexnts for application for clinical investigation of new drugs (TCM)
- Table 3.3: Data requirements for application for clinical investigation of new drugs (TCM preparations)
- Table 3.4: Data requirements for application for clinical investigation of new drugs (TCM materials)
- Table 3.5: Data requirements for application for clinical investigation of new drugs (TCM preparations)
- Table 4.1: Adverse drug reaction monitoring centres
- Table 9.1: Proportion of major synthetic drug types for export 1994-97 (%)
- Table 9.2: Export of three main bulk drug types (tons)
- Table 9.3: Output of 24 major chemical medicines in 1997
- Table 9.4: Output of five major preparation types in 1997
- Table 9.5: State-approved genetically engineered drugs for production
- Table 9.6: Productive ability and output of major preparations for traditional
Chinese medicine in 1997
- Table 9.7: Gross sales and growth of medicinal commodities before 1978
- Table 9.8: Gross sales and growth of medicinal commodities from 1978
- Table 9.9: Sales of medical commodities in China 1953-97
- Table 9.10: Sales of the four major medical commodities in urban and rural
areas in China 1979-94
LIST OF FIGURES
- Figure 1.1: Structure of the State Pharmacopoeia Committee
- Figure 2.1: Basic rules of DAL - from research and development to post-market
- Figure 2.2: Issuance of the 'Three Licences'
- Figure 3.1: General procedure for new drug approval
- Figure 3.2: Accelerated procedure for new drug approval
- Figure 3.3: Technology transfer of new drugs - approval procedure
- Figure 3.4: Application procedures for generic drugs
- Figure 3.5: Registration and approval procedures for imported drugs
- Figure 3.6: Quality standard revalidation procedures
- Figure 3.7: Approval procedures for clinical investigation
- Figure 3.8: Approval procedures for renewal of drug import registration
- Figure 3.9: Procedures for examination and ratification of supplementary applications
- Figure 3.10: Procedures for revalidation of imported drugs
- Figure 3.11: Procedures for import examination
- Figure 9.1: Circulation of drugs
- Figure 9.2: Sales growth of medical commodities, 1978-97
- Figure 9.3: Urban and rural sales of four major kinds of medical commodities, 1979-94
AbstractIn a unique collaboration China Concept Consulting, the Chinese Information Centre of The State Drug Administration (SDA) and Informa Pharmaceuticals have prepared the China Pharmaceuticals Guide - a definitive reference manual to the regulation of pharmaceuticals in this exciting market.
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