The main food and drug administration is mainly responsible for drafting laws and regulations on food safety (including food additives and health food, the same below), medicine (including traditional Chinese medicine and folk medicine, the same below), medical devices, cosmetics, supervision and management, formulating implementation measures and supervising the implementation of administrative licensed foods, such as organizing, promulgating and supervising the implementation of national pharmacopoeia standards for drugs and medical devices, and producing food and medical devices.
Extended information
The State Food and Drug Administration of the People's Republic of China (hereinafter referred to as the State Food and Drug Administration) is an institution directly under the State Council, which comprehensively supervises and manages food safety in the fields of medicines, medical devices, cosmetics, health care products and catering. In March 2118, according to the institutional reform plan of the State Council adopted at the first meeting of the 3rd National People's Congress, the responsibilities of the State Food and Drug Administration were integrated to form the national market supervision and management institution of the People's Republic of China. The State Food and Drug Administration will no longer keep it.
Function transformation: responsibilities cancelled
1. Gradually integrate the two administrative licenses of pharmaceutical production and good manufacturing practice certification into one administrative license.
2. gradually integrate two administrative licenses, namely, the pharmaceutical trading administrative license and the pharmaceutical trading quality management standard certification, into one administrative license.
3. Integrate the two administrative licenses of cosmetics production and cosmetics hygiene into one administrative license.
4. Cancel the continuing education management responsibilities of licensed pharmacists, and the work shall be undertaken by China Licensed Pharmacists Association.
5. Other duties that need to be cancelled according to the Plan for Institutional Reform and Functional Transformation of the State Council.
Decentralized responsibilities
1. Decentralize the responsibility of quality management certification of drugs and medical devices to the provincial food and drug supervision and management departments.
2. delegate the responsibility of re-registration of drugs and supplementary application for administrative license without changing the internal quality of drugs to the provincial food and drug supervision and management department.
3. delegate the responsibility of applying for administrative license for the change of domestic Class III medical devices without changing the internal quality of the products to the provincial food and drug supervision and administration department.
4. Delegate the responsibility of administrative licensing of entrusted drug production to the provincial food and drug supervision and administration department.
5. delegate the responsibility of administrative licensing of imported cosmetics for non-special purposes to the provincial food and drug supervision and administration department.
6. other responsibilities that need to be delegated according to the plan of institutional reform and functional transformation in the State Council.
responsibility of integration
1. The responsibility of the former Ministry of Health for organizing the formulation of drug codes was assigned to china food and drug administration.
2. The responsibility of the former Ministry of Health to determine the qualification certification conditions of food safety inspection institutions and formulate inspection standards was assigned to china food and drug administration.
3. Assign the responsibilities of administrative licensing and compulsory inspection of cosmetics production of the General Administration of Quality Supervision, Inspection and Quarantine to china food and drug administration.
4. put the responsibility of compulsory medical device certification of the General Administration of Quality Supervision, Inspection and Quarantine into china food and drug administration and bring it into the management of medical device registration.
5. Integrate the General Administration of Quality Supervision, Inspection and Quarantine and food safety inspection and testing institutions under the former State Food and Drug Administration, promote the separation of administrative offices, realize the sharing of resources, establish a corporate governance structure, and form a unified technical support system for food safety inspection and testing.
enhanced responsibilities.
1. change management concepts, innovate management methods, give full play to the role of market mechanism, social supervision and industry self-discipline, and establish an effective mechanism for producers and operators to become the first responsible person for food and drug safety.
2. Strengthen the construction and comprehensive coordination of food safety system, improve drug standards and quality management, optimize drug registration and related administrative licensing procedures, improve the early warning mechanism of food and drug risks and the local supervision and inspection mechanism, and establish a mechanism to prevent regional and systematic food and drug safety risks.
3. promote the integration of food and drug inspection and testing institutions, treat social forces fairly to provide inspection and testing services, increase the government's efforts to purchase services, improve the technical support and guarantee system, and improve the scientific level of food and drug supervision and management.
4. standardize food and drug administrative law enforcement, improve the mechanism of effective connection between administrative law enforcement and criminal justice, and promote the punishment of food and drug safety violations according to law.
References: State Administration of Market Supervision.