According to the Guidelines for Industry Classification of Listed Companies (revised 20 12) formulated by China Securities Regulatory Commission, the pharmaceutical industry belongs to "pharmaceutical manufacturing industry" (classification code C27).
(two) the competent department of industry, supervision system, major laws, regulations and policies.
1, the competent department of the industry The competent department of China's pharmaceutical industry is the National Pharmaceutical Products Administration under the State Administration of Market Supervision, which is responsible for the supervision and management of the national pharmaceutical market. The National Health and Wellness Commission, the National Health Insurance Bureau, the Ministry of Industry and Information Technology and the Ministry of Ecology and Environment jointly supervise and manage pharmaceutical enterprises, and the local drug supervision and administration departments at all levels are responsible for the drug supervision and administration within their respective administrative areas.
(1) State Administration of Medical Products
The State Administration of Pharmaceutical Products is the direct administrative department of China's pharmaceutical industry, responsible for the safety supervision and management of drugs, medical devices and cosmetics and the formulation of supervision and management policy planning; Responsible for organizing the formulation of national pharmacopoeia and other industry standards, organizing the formulation of classification management system, and supervising the implementation; Responsible for formulating the registration management system and strictly approving the listing; Responsible for the formulation, production, operation and use of quality management standards and supervise the implementation; Responsible for the risk management of drugs, medical devices and cosmetics after listing, and undertake safety emergency management according to law.
(2) National Health and Wellness Committee
The National Health Commission is responsible for organizing the formulation of national health policies and coordinating the allocation of health resources; Coordinate and promote the deepening of the reform of the medical and health system, and organize and deepen the comprehensive reform of public hospitals; Formulate and organize the implementation of disease prevention and control plans, national immunization plans and intervention measures for public health problems that seriously endanger people's health, and formulate a list of quarantine infectious diseases and a list of infectious disease monitoring; Responsible for health emergency work, organize and guide the prevention and control of public health emergencies and medical and health rescue of various public health emergencies; Organize the formulation of national drug policy and national essential drug system, and put forward suggestions on national essential drug price policy.
(3) National Health Insurance Bureau
The National Health Insurance Bureau is responsible for drafting the draft regulations, policies, plans and standards of medical insurance systems such as medical insurance, maternity insurance and medical assistance, formulating departmental rules and organizing their implementation; Organize the formulation of unified urban and rural medical insurance catalogues and payment standards for drugs, medical consumables, medical service items and medical service facilities, establish a dynamic adjustment mechanism, formulate negotiation rules for access to medical insurance catalogues and organize their implementation.
(4) Ministry of Industry and Information Technology
The Ministry of Industry and Information Technology is responsible for organizing the formulation and implementation of plans, policies and standards related to biomedicine, new materials, aerospace and information industries in high-tech industries; Organize the formulation of industrial technical specifications and standards to guide the quality management of the industry; Organize and implement the basic work of industry technology; Organize major industrialization demonstration projects; Organize the implementation of major national science and technology projects, and promote the combination of scientific and technological innovation and Industry-University-Research.
(5) The Ministry of Ecology and Environment is responsible for establishing and perfecting the basic system of ecological environment; Responsible for ecological environment monitoring; Responsible for the supervision and management of pollution prevention and control related to the pharmaceutical industry; The newly-started projects of pharmaceutical enterprises can only be started after being approved by the local competent department for environmental assessment.
2. Industry Supervision System (1) Drug Registration Management System
In order to standardize drug registration and ensure the safety, effectiveness and controllable quality of drugs, the State Administration of Market Supervision has formulated the Measures for the Administration of Drug Registration (revised in 2020), which is applicable to all drug research and development, registration, supervision and management activities aimed at drug listing in China.
1 drug registration drug registration refers to the activities in which an applicant for drug registration submits supplementary applications such as clinical trials, drug marketing license and re-registration according to legal procedures and relevant requirements, and the drug supervision and administration department reviews its safety, effectiveness and quality controllability according to laws and regulations and existing scientific knowledge, and decides whether to approve the application. After obtaining the drug registration certificate, the applicant is the holder of the drug marketing license.
2 drug listing permit holder system
According to the provisions of the Drug Administration Law of People's Republic of China (PRC), the drug marketing license holder (MAH) system refers to the system in which drug research and development institutions, scientific researchers, pharmaceutical production enterprises and other subjects with drug technology apply for and obtain the approval documents of drug marketing license, and assume the main responsibility of drug quality in their whole life cycle. The holder of the Drug Marketing License can produce drugs by himself or entrust a drug production enterprise to produce drugs.
3 drug classification registration management system
According to the Measures for the Administration of Drug Registration, drug registration is classified and managed according to traditional Chinese medicine, chemical drugs and biological products. In order to cooperate with the implementation of the Measures for the Administration of Drug Registration, the State Administration of Pharmaceutical Products has formulated supplementary requirements such as Requirements for Registration Classification and Application Materials of Chemical Drugs, Requirements for Registration Classification and Application Materials of Biological Products and Requirements for Registration Classification and Application Materials of Traditional Chinese Medicine (Draft for Comment) to further clarify the specific registration management classification and related registration management requirements.