Main responsibilities (1) Responsible for the safety supervision and management of drugs (including traditional Chinese medicine and ethnic medicine, the same below), medical devices and cosmetics. To formulate policies and plans for supervision and management, organize the drafting of draft regulations, formulate departmental rules and regulations, and supervise their implementation. To study and formulate management and service policies to encourage new technologies and products of drugs, medical devices and cosmetics.
(two) responsible for the management of drugs, medical devices and cosmetics standards. Organize the formulation and release of national pharmacopoeia and other standards for drugs and medical devices, organize the formulation of cosmetics standards, organize the formulation of classification management systems, and supervise the implementation. Participate in the formulation of the national essential drug list and cooperate with the implementation of the national essential drug system.
(three) responsible for the registration and management of drugs, medical devices and cosmetics. Formulate a registration management system, strictly approve the listing, improve the measures to facilitate the examination and approval services, and organize their implementation.
(four) responsible for the quality management of drugs, medical devices and cosmetics. Formulate and develop quality management standards and supervise their implementation. Formulate production quality management standards according to responsibilities and supervise their implementation. Formulate operation and use quality management standards and guide their implementation.
(five) responsible for the risk management of drugs, medical devices and cosmetics after listing. Organize the monitoring, evaluation and disposal of adverse drug reactions, medical device adverse events and cosmetic adverse reactions. To undertake the safety emergency management of drugs, medical devices and cosmetics according to law.
(six) responsible for the management of the qualification of licensed pharmacists. Formulate the qualification access system for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.
(seven) responsible for organizing and guiding the supervision and inspection of drugs, medical devices and cosmetics. Formulate an inspection system, investigate and deal with illegal acts in the registration of drugs, medical devices and cosmetics according to law, and organize and guide the investigation and handling of illegal acts in the production process according to responsibilities.
(eight) responsible for foreign exchanges and cooperation in the field of supervision and management of drugs, medical devices and cosmetics, and participate in the formulation of relevant international regulatory rules and standards.
(nine) responsible for guiding the work of drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government.
(ten) to complete other tasks assigned by the CPC Central Committee and the State Council.
(1 1) functional transformation.
1. Further promote decentralization. Reduce specific administrative examination and approval items, and gradually cancel or change the examination and approval items such as advertisements for drugs and medical devices, clinical trial institutions for drugs, and filing of imported cosmetics for non-special purposes. New raw materials of cosmetics shall be subject to classified management, high-risk products shall be subject to licensing management, and low-risk products shall be subject to filing management.
2. Strengthen post-event supervision. Improve the life-cycle management system of drugs and medical devices, strengthen the quality and safety risk management in the whole process, innovate supervision methods, strengthen credit supervision, comprehensively implement "double random, one open" and "internet plus supervision", improve supervision efficiency, and meet the public's demand for drugs and devices in the new era.
3. Effectively improve the service level. Accelerate the review and approval of innovative drugs and medical devices, establish a listing license holder system, promote electronic review and approval, optimize processes, improve efficiency, and create an environment that encourages innovation and protects legitimate rights and interests. Timely release the application information of drug registration, and guide the applicants to declare in an orderly manner.
4. Fully implement regulatory responsibilities. In accordance with the requirements of "the strictest standards, the strictest supervision, the most severe punishment and the most serious accountability", we will improve the evaluation, inspection and monitoring system for drugs, medical devices and cosmetics and improve the professionalism of the supervision team. Accelerate the consistency evaluation of generic drug quality and efficacy, promote the construction of traceability system, implement the main responsibility of enterprises, prevent systematic and regional risks, and ensure the safety and effectiveness of drugs and medical devices.
(12) Division of responsibilities.
1. Division of responsibilities with the State Administration of Market Supervision. The State Administration of Pharmaceutical Products is responsible for formulating the regulatory system for drugs, medical devices and cosmetics, and for licensing, inspection and punishment of the development of drugs, medical devices and cosmetics. Provincial drug supervision and management departments are responsible for the licensing, inspection and punishment of drugs, medical devices and cosmetics production links, as well as the filing, inspection and punishment of drug wholesale licenses, retail chain headquarters licenses and third-party platforms for Internet sales. The market supervision departments at the city and county levels are responsible for the licensing, inspection and punishment of drug retail and medical device business, as well as the inspection and punishment of the quality of cosmetics business and the use of drugs and medical devices.
2. Division of responsibilities with the National Health and Wellness Commission. The State Drug Administration, together with the National Health and Wellness Commission, organized the National Pharmacopoeia Committee, formulated the National Pharmacopoeia, and established a mutual notification mechanism and a joint disposal mechanism for major adverse drug reactions and medical device adverse events.
3. Division of responsibilities with the Ministry of Commerce. The Ministry of Commerce is responsible for formulating the development plans and policies for drug circulation, and the State Administration of Pharmaceutical Products cooperates with the implementation of the development plans and policies for drug circulation in drug supervision and management. The Ministry of Commerce shall obtain the consent of the State Administration of Pharmaceutical Products before issuing the Import License for Pharmaceutical Precursor Chemicals.
4. Division of responsibilities with the Ministry of Public Security. The Ministry of Public Security is responsible for organizing and guiding the investigation of crimes involving drugs, medical devices and cosmetics. The State Administration of Pharmaceutical Products and the Ministry of Public Security have established a linkage mechanism between administrative law enforcement and criminal justice. If the pharmaceutical supervisory and administrative department finds that an illegal act is suspected of committing a crime, it shall promptly transfer it to the public security organ in accordance with the relevant provisions, and the public security organ shall promptly review it and make a decision on whether to file a case according to law. If the public security organ requests the pharmaceutical supervisory and administrative department to assist in the inspection, appraisal and appraisal according to law, the pharmaceutical supervisory and administrative department shall provide assistance.