The State Food and Drug Administration of the United States is directly affiliated to the State Council to comprehensively supervise the safety management and drug supervision of food, health products and cosmetics, and is responsible for the research, production, circulation and distribution of drugs (including Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, biological products, diagnostic drugs, radioactive drugs, narcotic drugs, toxic drugs, psychotropic drugs, medical devices, sanitary materials, medical packaging materials, etc.). ). Responsible for the comprehensive supervision, organization and coordination of food, health care products and cosmetics safety management, and organize the investigation and handling of major accidents according to law; Responsible for the examination and approval of health care products. Its main responsibilities are:
(1) Organizing relevant departments to draft laws and administrative regulations on the safety management of food, health products and cosmetics; Organize relevant departments to formulate comprehensive supervision policies and work plans for food, health care products and cosmetics safety management and supervise their implementation.
(two) to exercise the comprehensive supervision duties of food, health care products and cosmetics safety management according to law, and organize and coordinate the safety supervision of food, health care products and cosmetics undertaken by relevant departments.
(three) to organize the investigation and handling of major safety accidents of food, health care products and cosmetics according to law; According to the authorization of the State Council, organize and coordinate the national food, health care products, cosmetics safety special law enforcement supervision activities; Organize, coordinate and cooperate with relevant departments to carry out emergency rescue work for major accidents of food, health care products and cosmetics.
(four) comprehensive coordination of food, health care products and cosmetics safety testing and evaluation; In conjunction with the relevant departments, formulate measures for the release of food, health care products and cosmetics safety supervision information and supervise the implementation, and regularly and comprehensively release the food, health care products and cosmetics safety information of relevant departments to the society.
(5) Drafting laws and administrative regulations on drug administration and supervising their implementation; Implement the protection system of traditional Chinese medicine varieties and the administrative protection system of drugs according to law.
(6) Drafting laws and administrative regulations on the management of medical devices and supervising their implementation; Responsible for the registration, supervision and management of medical device products; Draft relevant national standards, formulate and revise industry standards and production quality management norms for medical device products, and supervise their implementation.
(7) Drug registration, drafting, revising and promulgating national drug standards; Formulate market access standards for health care products and be responsible for the examination and approval of health care products; Formulate a classified management system for prescription drugs and over-the-counter drugs, establish and improve a monitoring system for adverse drug reactions, and be responsible for drug re-evaluation, audit of eliminated drugs and formulation of the national essential drug list.
(eight) to formulate and revise the quality management standards for drug research, production, circulation and use, and supervise the implementation.
(nine) to supervise the quality of drugs and medical devices in production and operation enterprises and medical institutions, and regularly publish national quality bulletins on drugs and medical devices; Investigate and deal with illegal activities such as manufacturing and selling counterfeit and inferior drugs and medical devices according to law.
(ten) according to the supervision of radioactive drugs, narcotic drugs, toxic drugs, psychotropic drugs and special drugs.
(1) Formulate the qualification recognition system for licensed pharmacists (including licensed pharmacists) to guide the qualification examination and registration of licensed pharmacists (including licensed pharmacists).
(eleven) to formulate and improve the qualification access system for licensed pharmacists, and supervise and guide the registration of licensed pharmacists.
(twelve) to guide the national drug supervision and management and the comprehensive supervision of food, health care products and cosmetics safety management.
(thirteen) to carry out exchanges and cooperation between governments and international organizations related to drug supervision and management and food, health care products and cosmetics safety management.
(fourteen) to undertake other tasks assigned by the State Council. Pharmacopoeia Committee was first established in 1950. It is the earliest standardized management organization after the founding of New China, and a professional technical management committee responsible for formulating and revising national drug standards. The National Pharmacopoeia Committee is the statutory body of the national drug standardization management.
The basic function of the National Pharmacopoeia Committee is to be responsible for the management of national drug standards.
The first Committee of National Pharmacopoeia Committee was established in 1950, and the eighth Committee was established in 10 in 2002.
The permanent offices of the National Pharmacopoeia Committee shall implement the Secretary-General responsibility system.
After the establishment of the Eighth Pharmacopoeia Committee, the compilation of the 2005 edition of China Pharmacopoeia officially began. The 2005 edition of Pharmacopoeia consists of one part (traditional Chinese medicine), two parts (western medicine) and three parts (biological products), which improves the drug standard system in China. The Drug Evaluation Center of the State Administration of Pharmaceutical Products is the technical functional organization of drug technical evaluation. Its main responsibilities are
(1) Be responsible for the technical review of new drug applications for chemicals, biological products and in-vitro diagnostic reagents according to the Measures for the Administration of Drug Registration and relevant laws and regulations.
2) Be responsible for the technical review of the application for new Chinese medicine according to the Measures for the Administration of Drug Registration and relevant laws and regulations.
(3) To be responsible for the technical review of applications for imported drugs in accordance with the Measures for the Administration of Drug Registration and relevant laws and regulations.
(4) According to the Measures for the Administration of Drug Registration and relevant laws and regulations, be responsible for the technical review of the application for existing national standard drugs.
(5) To undertake other tasks assigned by the State Administration of Pharmaceutical Products.
The State Administration of Pharmaceutical Products has set up seven functional departments for the drug evaluation center, which are responsible for drug evaluation. The Drug Evaluation Center of the State Administration of Pharmaceutical Products is a technical functional department to re-evaluate drugs that have been approved for production and marketing. Its main responsibilities are:
(1) Technical business organization and related work responsible for the formulation and adjustment of the national essential drugs list.
(2) Technical business organization and related work responsible for the formulation and adjustment of OTC drug list.
(3) Responsible for the technical business organization and related work of drug reevaluation and drug elimination and screening during the trial production and after listing.
(4) To be responsible for the technical business organization and related work of the national monitoring of adverse reactions of drugs and medical devices.
(5) To undertake other tasks assigned by the State Administration of Pharmaceutical Products.
The National Adverse Drug Reaction Monitoring Center, located in the Drug Evaluation Center of the State Administration of Pharmaceutical Products, is responsible for the national adverse drug reaction monitoring of drugs and medical devices. On June 4th, 1992, 10, the State Council issued the Regulations on the Protection of Traditional Chinese Medicine Varieties. According to the "Regulations" 1993 and 10, the National Evaluation Committee for the Protection of Traditional Chinese Medicine Varieties was established to be responsible for evaluating the varieties of traditional Chinese medicine that applied for protection. It is a professional technical review and technical consultation institution for the protected varieties of traditional Chinese medicine approved by the state.
The National Evaluation Committee for the Protection of Traditional Chinese Medicine Varieties has an office, which is the daily office of the State Administration of Pharmaceutical Products, and is responsible for implementing and handling the daily affairs and technical consultation of the Committee for the Protection of Traditional Chinese Medicine Varieties. As a public institution directly under the State Administration of Pharmaceutical Products, the Drug Certification Management Center of the State Administration of Pharmaceutical Products is responsible for the specific work of drug certification.
(1) Participate in the formulation and revision of Good Quality Management Practices for Non-clinical Research of Drugs (GLP), Good Quality Management Practices for Clinical Trials of Drugs (GCP), good manufacturing practice (GMP), Good Quality Management Practices for Pharmaceutical Trading (GSP),
"GAP" and "GAP" and their corresponding management measures.
(2) Entrusted by the State Administration of Pharmaceutical Products, in accordance with the requirements of division of labor, organize on-site inspection and certification of pharmaceutical research institutions, clinical trial institutions, pharmaceutical production enterprises, pharmaceutical trading enterprises and preparation rooms of medical institutions.
(3) Organizing the establishment of a database of national drug certification inspectors; To undertake the training, assessment and appointment of drug certification inspectors; To undertake the training of drug certification inspectors and certification managers in provincial drug supervision and administration departments.
(4) Organize the training of managers and technicians of units and enterprises related to the above provisions.
(5) Entrusted by the State Administration of Pharmaceutical Products, responsible for the specific work of drug certification announcement.
(6) according to the arrangement of the national competent department, carry out academic exchange activities at home and abroad for drug certification; Undertake the specific work of international drug mutual recognition.
(7) To undertake other tasks assigned by the State Administration of Pharmaceutical Products.