China Pharmaceuticals Guide

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
Drug Registration Department
Medical Devices Division
Safety Regulation Department
Market Supervision Department
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

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
Drugs
Biological products
New drugs
New biological products
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
Criminal liabilities
Civil liability
Administrative 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

Administration of approval of new drugs
Definition and scope of new drugs
Classification of new drugs
Traditional Chinese medicine (TCM)
Synthetic drugs
Biological products
Change of classification and identification
Preclinical investigation of a new drug
Clinical investigation of new drugs
Phasing of the clinical trials
Biological equivalency tests
Basic conditions for clinical investigation
Selection and confirmation of new drug clinical investigation institutions
Duties of the sponsoring institution in the clinical investigation
Duties of the new drug clinical investigation institutions
Exemptions in clinical investigation
Special requirements for clinical investigation of biological products
Application and approval of new drugs
General procedure and requirements for approval
Accelerated procedure and requirements
State-level approval for new biological products
Specific requirements for the new drug applications
Principles for refusing new drug applications
Information and data needed for new drug applications
Synthetic drugs
TCM raw materials
TCM preparations
New biological products for therapeutic use
New biological products for preventive use
External diagnostic products
Document format and number of copies to be submitted
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
TCM preparations
Synthetic drugs
Drug substance (including auxiliary substances)
Preparations
Biological products
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

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)
Taking an active part in the revision of GMP
Taking GMP authentication and supervision as an important measure in drug production management
Supervision, assistance and promotion as basic policy in GMP implementation
Administration of drug classification and the National Basic Drug List system
Significance and basic principles of administration of drug classification
Significance of drug classification
Fundamental principles of drug classification
Outline of drug classifications
Concepts of prescription and non-prescription medicines
Production of prescription and non-prescription medicines
Distribution of prescription and non-prescription medicines
Advertising of prescription and non-prescription medicines
Plan and objectives of drug classification
System of National Basic Drugs
Guidelines for the making of the National Basic Drug List
Principles of the National Basic Drug List
Adverse reactions and post-market re-evaluation of drugs
Monitoring centres and networks on adverse drug reactions
International standards
Post-market re-evaluation of drugs
Lessons learned from major drug-induced injuries
Limitations of new medicine inspection and ratification systems
Content of re-evaluation of drugs that have been put on the market
Administration of drugs for special uses
Administration of toxic drugs for medical use
Administration of anaesthetics
Administration of psychotropic drugs
Administration of radioactive drugs
Administration of anti-narcotic drugs

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
Wholesale
Retail
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
Acceptance and registration of the cases
Investigation and collection of evidence
Administrative penalties
Execution and close of a case
Responsibilities and divisions of administrative penalty work on counterfeit and poor-quality medicines
Medical administrations
Medicine quality control offices
Medicine supervisors
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
Examination system at the state and province levels
Documents and information for examination
Guidelines for medicine advertisement examinations
Other regulations related to medicine advertisement administration and examination

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
Work entrusted to the China Chemical Pharmacy Industry Association
Work entrusted to the National Technology Market Association
Work entrusted to the China Medical Enterprise Administration Association
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'
Optimisation of resource allocation
New drug development system and technological progress
GMP quality assurance system
Establishing the modern pharmaceutical enterprise system
Developing the export-oriented pharmaceutical economy
Emphasising environmental protection
Expediting the development of the medical information industry
Foreign investment policies and guidelines on foreign investment
Fundamental policies for foreign investment in the pharmaceutical industry
Foreign investment guidance in the medical industry
Encouraged areas
Restricted areas
Prohibited areas

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
Manufacturers' prices of various drugs (TCM materials and herbal decoctions excluded)
Synthetic drugs
Traditional Chinese medicine preparations
Biological products
Biochemical drugs
Wholesale prices of various drugs (TCM materials and herbal decoctions excluded)
Retail prices of various drugs (TCM materials and herbal decoctions excluded)
Price of imported drugs
Price of anaesthetics
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
Bibliography

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

Development of the pharmaceutical industry
Scope and overview of the pharmaceutical industry
Scope of the pharmaceutical industry
Rapid development of the pharmaceutical industry
Achievements of opening the pharmaceutical industry to international forces
Continuous improvement of drug quality
Extending enterprise reform and rationalising the structure of production
Synthetic pharmaceutical industry
Synthetic pharmaceutical industry maintenance of high growth
Increased product variety and rationalised structures
Development of modern biological medicines
Traditional Chinese medicine industry
Sources of traditional Chinese medicine material
Modernisation of the traditional Chinese medicine industry
Steady increase of the traditional Chinese medicine industry
Development of the medicine business
Distribution model for medicines
National medicine business enterprises
Regional medicine business enterprises
Grassroots-level wholesale dealers
China's medicine market
Market scale
Characteristics of the medicine market
Development trends
Prospect of China's medicine market
Development trends of China's medicine trade
Reform of enterprises
Circulation model
Intellectual property rights of medicines and development of new medicines
Development and perfection of protecting intellectual property rights of medicines
Trademark Law and medicine trademark management
Patent Law and protection of patent on medical products
Administrative protection of medicinal commodities
Background of 'Administrative Protection Concerning Medicinal Commodities'
Regulations of 'Administrative Protection Concerning Medicinal Commodities'
Medicinal Commodities Administrative Protection Office and Medicinal Commodities Administrative Protection Reappraising Committee
Research and exploitation of new medicines
Exploitation of new medicines is the foundation for the Chinese medicine industry
Research and exploitation of new medicines shifting from imitation to innovation
Chinese medicine displaying a wide prospect for international co-operation of new medicine research and exploitation
Development of medical education
Higher medical education
Secondary medical education
Ordinary secondary school education
Technical medical education
Continuous education in the medicine trade
Emergence and continuation of post-training of employees in the medicine trade

Table 3.1: Data requirements for application for clinical investigation of new drugs (synthetic)
Table 3.2: Data requirements 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

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