| Notice of the General Office of the CPC Central Committee and the General Office of the State Council on Issuing the Provisions on the Functions, Structure and Staffing of the National Medical Products Administration | | 中共中央办公厅、国务院办公厅关于印发《国家药品监督管理局职能配置、内设机构和人员编制规定》的通知 |
| (No. 53 [2018] of the General Office of the CPC Central Committee) | | （厅字[2018]53号） |
| The Party committees and the people's governments of all provinces, autonomous regions and municipalities directly under the Central Government; all departments and commissions under the CPC Central Committee, and all ministries and commissions under the State Council; all entities of the People's Liberation Army; all departments of the Central Military Commission; and all people's organizations: | | 各省、自治区、直辖市党委和人民政府，中央和国家机关各部委，解放军各大单位，中央军委机关各部门，各人民团体： |
| The Provisions on the Functions, Structure and Staffing of the National Medical Products Administration, as examined by the State Commission Office of Public Sectors Reform, have been reported to the CPC Central Committee and the State Council for approval, and are hereby issued. | | 《国家药品监督管理局职能配置、内设机构和人员编制规定》经中央机构编制委员会办公室审核后，已报党中央、国务院批准，现予印发。 |
| General Office of the CPC Central Committee | | 中共中央办公厅 |
| General Office of the State Council | | 国务院办公厅 |
| July 29, 2018 | | 2018年7月29日 |
| Provisions on the Functions, Structure and Staffing of the National Medical Products Administration | | 国家药品监督管理局职能配置、内设机构和人员编制规定 |
| Article 1 These Provisions are developed in accordance with the Decision of the CPC Central Committee on Deepening the Institutional Reform of the Party and State and the Plan for Deepening the Institutional Reform of the Party and State deliberated and adopted at the Third Plenary Session of the 19th CPC Central Committee, and the State Council Institutional Reform Proposal approved at the First Session of the Thirteenth National People's Congress. | | 第一条 根据党的十九届三中全会审议通过的《中共中央关于深化党和国家机构改革的决定》、《深化党和国家机构改革方案》和第十三届全国人民代表大会第一次会议批准的《国务院机构改革方案》,制定本规定。 |
| Article 2 The National Medical Products Administration (“NMPA”) is a national bureau at the deputy ministerial level administered by the State Administration for Market Regulation. | | 第二条 国家药品监督管理局是国家市场监督管理总局管理的国家局,为副部级。 |
| Article 3 The NMPA shall implement the guidelines, policies, and decisions and arrangements of the CPC Central Committee on the supervision and administration of medical products, and adhere to and strengthen the Party's centralized and unified leadership over the supervision and administration of medical products in the process of performing its functions. Its main functions are as follows: | | 第三条 国家药品监督管理局贯彻落实党中央关于药品监督管理工作的方针政策和决策部署,在履行职责过程中坚持和加强党对药品监督管理工作的集中统一领导。主要职责是: |
| (1) Being responsible for the supervision and administration of the safety of drugs (including traditional Chinese medicine (“TCM”), and ethnic medicine, here and below), medical devices and cosmetics. Drawing up supervision and administration policy planning, organizing the drafting of draft laws and regulations, drawing up departmental rules, and supervising the implementation thereof. Researching and drafting the administration and service policies that encourage new technologies and new products for drugs, medical devices and cosmetics. | | (一)负责药品(含中药、民族药,下同)、医疗器械和化妆品安全监督管理。拟订监督管理政策规划,组织起草法律法规草案,拟订部门规章,并监督实施。研究拟订鼓励药品、医疗器械和化妆品新技术新产品的管理与服务政策。 |
| (2) Being responsible for the administration of standards for drugs, medical devices and cosmetics. Organizing the development and issuance of Chinese Pharmacopoeia and other drug and medical device standards, organizing the drafting of cosmetic standards, and organizing the development of the classified administration system, and supervising the implementation thereof. Participating in the development of the National Essential Medicine List, and supporting the implementation of the national essential medicine system. | | (二)负责药品、医疗器械和化妆品标准管理。组织制定、公布国家药典等药品、医疗器械标准,组织拟订化妆品标准,组织制定分类管理制度,并监督实施。参与制定国家基本药物目录,配合实施国家基本药物制度。 |
| (3) Being responsible for the administration of registration of drugs, medical devices and cosmetics. Developing a registration administration system, strictly conducting the review and approval of marketing, improving the facilitation measures for review and approval services, and organizing the implementation thereof. | | (三)负责药品、医疗器械和化妆品注册管理。制定注册管理制度,严格上市审评审批,完善审评审批服务便利化措施,并组织实施。 |
| (4) Being responsible for the quality management of drugs, medical devices and cosmetics. Developing quality management practices and supervising the implementation thereof. Developing good manufacturing practices (GMP) and supervising the implementation thereof according to its functions. Developing operation and use quality management practices and guiding the implementation thereof. | | (四)负责药品、医疗器械和化妆品质量管理。制定研制质量管理规范并监督实施。制定生产质量管理规范并依职责监督实施。制定经营、使用质量管理规范并指导实施。 |
| (5) Being responsible for risk management of drugs, medical devices and cosmetics after their marketing. Organizing the monitoring, evaluation and disposition of adverse drug reactions, adverse medical device events and adverse cosmetic reactions. Undertaking the emergency management of the safety of drugs, medical devices and cosmetics according to the law. | | (五)负责药品、医疗器械和化妆品上市后风险管理。组织开展药品不良反应、医疗器械不良事件和化妆品不良反应的监测、评价和处置工作。依法承担药品、医疗器械和化妆品安全应急管理工作。 |
| (6) Being responsible for the administration of the qualification access of licensed pharmacists. Developing a system for the qualification access of licensed pharmacists and guiding and supervising the registration of licensed pharmacists. | | (六)负责执业药师资格准入管理。制定执业药师资格准入制度,指导监督执业药师注册工作。 |
| (7) Being responsible for organizing and guiding the supervision and inspection of drugs, medical devices and cosmetics. Developing an inspection system, investigating and punishing illegal activities during the registration of drugs, medical devices and cosmetics according to the law, and organizing and guiding the investigation and punishment of illegal activities in the process of manufacturing. | | (七)负责组织指导药品、医疗器械和化妆品监督检查。制定检查制度,依法查处药品、医疗器械和化妆品注册环节的违法行为,依职责组织指导查处生产环节的违法行为。 |
| (8) Being responsible for the foreign exchange and cooperation in the field of supervision and administration of drugs, medical devices and cosmetics, and participating in the development of relevant international regulatory rules and standards. | | (八)负责药品、医疗器械和化妆品监督管理领域对外交流与合作,参与相关国际监管规则和标准的制定。 |
| (9) Being responsible for guiding the work of the drug supervision and administration departments of all provinces, autonomous regions, and municipalities directly under the Central Government. | | (九)负责指导省、自治区、直辖市药品监督管理部门工作。 |
| (10) Completing other tasks assigned by the CPC Central Committee and the State Council. | | (十)完成党中央、国务院交办的其他任务。 |
| (11) Transformation of functions. | | (十一)职能转变。 |
(a) Advancing the simplification of administrative procedures and decentralization of powers in an in-depth manner. Reducing specific administrative approval items, and gradually cancelling or changing to recordation administration of the drugs and medical device advertisements, drug clinical trial institutions, and imported non-special-purpose cosmetics and other approval items. Conducting classified administration of new raw materials for cosmetics, that is, conducting licensing administration for those high-risk ones, and conducting recordation administration for those low-risk ones.
．．．．．． | | 1.深入推进简政放权。减少具体行政审批事项,逐步将药品和医疗器械广告、药物临床试验机构、进口非特殊用途化妆品等审批事项取消或者改为备案。对化妆品新原料实行分类管理,高风险的实行许可管理,低风险的实行备案管理。
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