Measures for the Administration of National Essential Drugs List?
According to the spirit of "Opinions of the State Council, the Central Committee of the Communist Party of China on Deepening the Reform of the Medical and Health System", these measures are formulated to consolidate and improve the basic drug system and establish and improve the management mechanism for the selection and adjustment of the national essential drug list.
Article 1 Essential drugs refer to drugs that meet the basic medical and health needs, have appropriate dosage forms, are reasonably priced, can guarantee supply, and are fairly available to the public. All primary medical and health institutions organized by the government are equipped with and use essential drugs, and other medical institutions must also use essential drugs according to regulations.
Article 2 The drugs in the national list of essential drugs include chemicals, biological products, Chinese patent medicines and Chinese herbal pieces. Chemicals and biological products are mainly classified according to clinical pharmacology, while Chinese patent medicines are mainly classified according to functions.
Article 3 The National Essential Drugs Working Committee is responsible for coordinating and solving the relevant policy issues in all aspects of the formulation and implementation of the national essential drugs system, determining the framework of the national essential drugs system, determining the principles, scope, procedures and work plans for the selection and adjustment of the national essential drugs list, reviewing the national essential drugs list, and all relevant departments do a good job in the selection and adjustment of national essential drugs within the scope of their duties. The Committee is composed of National Health and Family Planning Commission, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Finance, Ministry of Human Resources and Social Security, Ministry of Commerce, State Food and Drug Administration, state administration of traditional chinese medicine and Ministry of Health of General Logistics Department. The office is located in the National Health and Family Planning Commission and undertakes the daily work of the National Essential Drugs Working Committee.
Article 4 The selection of national essential drugs shall follow the principles of prevention and treatment necessity, safety and effectiveness, reasonable price, convenient use, equal emphasis on Chinese and Western medicines, basic guarantee, first choice in clinical practice and availability at the grass-roots level, and reasonably determine the variety (dosage form) and quantity in combination with the characteristics of drug use in China and referring to international experience.
The formulation of the national list of essential drugs should be linked with the basic public health service system, the basic medical service system and the basic medical security system.
Article 5 The chemicals, biological products and proprietary Chinese medicines in the National Essential Drugs Catalogue shall be the varieties recorded in the Pharmacopoeia of People's Republic of China (PRC) and the drug standards published by the US Food and Drug Administration and the former Ministry of Health. In addition to first-aid and rescue drugs, the inclusion of exclusive production varieties in the national list of essential drugs should be independently demonstrated.
The names of chemicals and biological products are chemical components represented by Chinese common names and English international common drug names, and the dosage forms are listed separately; Chinese patent medicines adopt generic names.
Legal basis: Drug Administration Law of People's Republic of China (PRC).
catalogue
Chapter I General Provisions
Chapter II Drug Development and Registration
Chapter III Holders of Drug Marketing License
Chapter IV Pharmaceutical Production
Chapter V Pharmaceutical Trading
Chapter VI Pharmaceutical Affairs Management of Medical Institutions
Chapter VII Post-marketing Management of Drugs
Chapter VIII Drug Prices and Advertisements
Chapter IX Drug Reserve and Supply
Chapter X Supervision and Administration
Chapter II XI Legal Liability
Chapter XII Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to strengthening drug administration, ensuring drug quality, safeguarding the safety and legitimate rights and interests of the public in drug use, and protecting and promoting public health.
Article 2 This Law shall apply to the research, production, trading, use, supervision and administration of drugs within the territory of People's Republic of China (PRC).
Drugs mentioned in this Law refer to substances used for preventing, treating and diagnosing human diseases, purposefully regulating human physiological functions, and specifying indications or functional indications, usage and dosage, including traditional Chinese medicines, chemicals and biological products.
Article 3 Drug management should focus on people's health, adhere to the principles of risk management, whole-process control and social governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.
Article 4 The state develops modern medicine and traditional medicine and gives full play to their roles in prevention, medical treatment and health care.
The state protects wild medicinal resources and varieties of traditional Chinese medicine, and encourages the cultivation of genuine medicinal materials.
Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.
Article 6 The State implements the drug marketing license holder system for drug administration. The holder of the drug marketing license is responsible for the safety, effectiveness and quality controllability of the whole process of drug research and development, production, management and use according to law.
Article 7 In the research and development, production, marketing and use of drugs, laws, regulations, rules, standards and norms shall be observed to ensure the truthfulness, accuracy, completeness and traceability of the information in the whole process.
Article 8 The drug supervision and administration department of the State Council is in charge of drug supervision and administration throughout the country. The relevant departments of the State Council are responsible for drug supervision and administration within their respective functions and duties. The drug supervision and administration department of the State Council cooperates with the relevant departments of the State Council to implement the national drug industry development plan and industrial policy.