来源: CCFDIE平台
国家药品监督管理局机关各司局主要职责
Principal responsibilities of the departments and bureaus of National Medical Products Administration
综合和规划财务司
负责机关日常运转,承担信息、安全、档案、保密、信访、政务公开、统计、信息化、新闻宣传等工作。对重要政务事项开展督查督办。组织开展应急管理和舆情监测工作。拟订并组织实施发展规划和专项建设规划,推动监督管理体系和信息化建设。承担机关和直属单位预决算、财务、国有资产管理及内部审计工作。组织起草综合性文稿和重要会议文件。
Department of General Affairs, Planning and Finance
Responsibilities: 1.The daily operations of NMPA departments, undertaking the work related to information, security, confidentiality, public complaints and proposals, open government affairs, information technology, news publicity, etc. 2. Inspect, supervise and handle important government affairs. 3. Organize the implementation of emergency management and public opinion monitoring. 4. Mastermind, organize and implement development plans and special plans to drive the construction of administrative system and information system. 5. Undertake the budget and final accounts, finance, management of state-owned assets and internal audit for department organs and directly affiliated units. 6. Organize the drafting of documents of general affairs and important conference papers.
政策法规司
研究药品、医疗器械和化妆品监督管理重大政策。组织起草法律法规及部门规章草案。承担规范性文件的合法性审查工作。承担执法监督、行政复议、行政应诉、重大案件法制审核工作。承担行政执法与刑事司法衔接管理工作。承担普法宣传和涉及世界贸易组织的相关工作。承担全面深化改革的有关协调工作。承担疫苗质量管理体系QMS办公室日常工作。
Department of Policies and Legal Affairs
Responsibilities: 1. Research of significant policies for supervision and administration of drugs, medical devices and cosmetics. 2. Organize the drafting of laws, regulations and departmental rules. 3. Legality review of normative documents. 4. Law enforcement supervision, administrative reconsideration, responding to administrative lawsuits, and legal audit of major cases. 5. Seamless integration of administrative law enforcement and criminal justice. 6. Work related to elevating legal literacy and legal publicity, and to the World Trade Organization. 7. Coordination of work relative to comprehensively deepening reforms. 8. Routine administration of the Vaccine QMS Office.
药品注册管理司(中药民族药监督管理司)
组织拟订并监督实施国家药典等药品标准、技术指导原则,拟订并实施药品注册管理制度。监督实施药物非临床研究和临床试验质量管理规范、中药饮片炮制规范,实施中药品种保护制度。承担组织实施分类管理制度、检查研制现场、查处相关违法行为工作。参与制定国家基本药物目录,配合实施国家基本药物制度。
Department of Drug Registration (Department of TCMs and Ethno-Medicines Supervision)
Responsibilities: 1. Organize the formulation and supervise the implementation of drug standards and technical guidelines (such as Chinese Pharmacopoeia), formulate and implement drug registration management schemes. 2. Supervise the implementation of pharmaceutical non-clinical researches and Good Clinical Practice, the specifications for processing TCM slices; and implement the protection system for the categorization of TCM varieties. 3. Organize the implementation of the classified control system, inspect the R&D venues, and investigate and punish relevant illegal acts. 4. Participate in the development of the National Essential Drug List and cooperate in the implementation of the National Essential Drug System.
药品监督管理司
组织拟订并依职责监督实施药品生产质量管理规范,组织拟订并指导实施经营、使用质量管理规范。承担组织指导生产现场检查、组织查处重大违法行为。组织质量抽查检验,定期发布质量公告。组织开展药品不良反应监测并依法处置。承担放射性药品、麻醉药品、毒性药品及精神药品、药品类易制毒化学品监督管理工作。指导督促生物制品批签发管理工作。
Department of Drug Supervision
Responsibilities: 1. Organize the formulation and supervise, as per its powers and duties, the implementation of drug GMPs; organize the formulation and guide the implementation of the Good Supply Practice and Good Use Practice. 2. Organize and guide the on-site inspections over production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 4. Organize the monitoring of adverse reactions and law-based intervention thereof. 5. The supervision and administration of radioactive, narcotic, toxic, psychotropic drugs and pharmaceutical precursor chemicals.6. Guide and supervise the Registration Approval, Certificate Issuance and Product Release for biological products.
医疗器械注册管理司
组织拟订并监督实施医疗器械标准、分类规则、命名规则和编码规则。拟订并实施医疗器械注册管理制度。承担相关医疗器械注册、临床试验审批工作。拟订并监督实施医疗器械临床试验质量管理规范、技术指导原则。承担组织检查研制现场、查处违法行为工作。
Department of Medical Device Registration
Responsibilities: 1. Organize the formulation and supervise the implementation of standards, classification rules, nomenclature conventions and coding rules for medical devices. 2. Draw up and implement the registration management system for medical devices. 3. Undertake the relevant medical device registration and clinical trial examination and approval. 4. Draw up and supervise the implementation of the Good Clinical Practice for Medical Devices and technical guidelines for medical device clinical trials. 5. Organize the inspection of R&D venues, investigate and punish the illegal acts.
医疗器械监督管理司
组织拟订并依职责监督实施医疗器械生产质量管理规范,组织拟订并指导实施医疗器械经营、使用质量管理规范。承担组织指导生产现场检查、组织查处重大违法行为工作。组织质量抽查检验,定期发布质量公告。组织开展不良事件监测并依法处置。
Department of Medical Device Supervision
Responsibilities: 1. Organize the formulation and supervise, as per its powers and duties, the implementation of the GMPs for medical devices; organize the formulation and guide the implementation of the Good Supply Practice and Good Use Practice. 2. Organize and guide the on-site inspections over production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 4. Organize the monitoring of adverse reactions and law-based intervention thereof.
化妆品监督管理司
组织实施化妆品注册备案工作。拟订并组织实施化妆品注册备案和新原料分类管理制度。组织拟订并监督实施化妆品标准、分类规则、技术指导原则。承担拟订化妆品检查制度、检查研制现场、依职责组织指导生产现场检查、查处重大违法行为工作。组织质量抽查检验,定期发布质量公告。组织开展不良反应监测并依法处置。
Department of Cosmetics Supervision
Responsibilities: 1. Organize and implement the record filling of cosmetic registration. 2. Draw up and organize the implementation of cosmetics registration record filing and classified control system for new materials. 3. Organize the formulation and supervise the implementation of standards, classification rules and technical guidelines for cosmetics. 4. Work out the cosmetic inspection system, inspect the R&D venues, perform duty-based organization and guidance over the on-site inspections of production venues, investigate and punish serious illegal acts. 3. Organize random quality inspections and release Quality Announcements on a regular basis. 6. Organize the monitoring of adverse reactions and law-based intervention thereof.
科技和国际合作司(港澳台办公室)
组织研究实施药品、医疗器械和化妆品审评、检查、检验的科学工具和方法。研究拟订鼓励新技术新产品的管理与服务政策。拟订并监督实施实验室建设标准和管理规范、检验检测机构资质认定条件和检验规范。组织实施重大科技项目。组织开展国际交流与合作,以及与港澳台地区的交流与合作。协调参与国际监管规则和标准的制定。
Department of Science & Technology and International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs)
Responsibilities: 1. Organize the study of scientific tools and methods for implementing the review, inspection and testing of drugs, medical devices and cosmetics. 2. Study and draw up the management and service policies encouraging new technologies and new products. 3. Work out and supervise the implementation of laboratory construction standards and GLPs, the qualification accreditation conditions and inspection specifications for the inspection and testing institutions. 4. Organize the implementation of significant science & technology projects. 5. Organize and carry out exchange and cooperation with the world and Hong Kong, Macao and Taiwan regions. 6. Coordinate and participate in the development of international regulatory protocols and standards.
人事司
承担机关和直属单位的干部人事、机构编制、劳动工资和教育工作,拟订人事管理及干部监督制度并组织实施。统筹管理机关和直属单位机构编制,统筹管理工资、津贴补贴及直属单位绩效工资等。指导相关人才队伍建设工作,统筹管理干部培训,加强人才队伍建设。承担执业药师资格管理工作,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。
Department of Human Resources
Responsibilities: 1. Undertake the personnel affairs of the cadres in department organs and directly affiliated units, institutional staffing, labor wages and education; formulate and organize the implementation of personnel management system and cadre supervision system. 2. Coordinate the management of institutional staffing for department organs and directly affiliated units; the wages, allowances and subsidies of NMPA; as well as the pay-for-performance in directly affiliated units. 3. Guide the construction of relevant qualified personnel teams, coordinate management of cadre training, and strengthen the construction of talent teams. 4. Undertake the qualification management of licensed pharmacists, take charge of the qualification management of licensed pharmacists, lay down the qualification admittance system for licensed pharmacists, guide and supervise the registration in this respect.
机关党委
负责推进机关和在京直属单位党的政治建设、思想建设、组织建设、作风建设、纪律建设,把制度建设贯穿其中。对党员进行教育、管理、监督和服务。承担党风廉政建设和反腐败工作。指导直属机关群团组织开展工作,推进精神文明建设。承担局党组巡视工作,负责内部巡视的组织实施和中央巡视的协调配合。
Party committee
Responsibilities: 1. Promote the CPC political, ideological, organizational, work style-related, and disciplinary construction for NMPA organs and its directly affiliated units in Beijing, taking system construction as the mainline. 2. Conduct the management and supervision of CPC party members and provide education and service to them. 3. Undertake the Construction of Honest Party Conduct and Clean Government, as well as anti-corruption operations. 4. Guide the group league organizations (mass organizations) of NMPA directly affiliated organs to carry out work and promote the building up of spiritual civilization. 5. Undertake the inspection work of NMPA CPC Party Group, coordinate the organization and implementation of the internal inspection and the Central Party Committee inspection.
离退休干部局
负责机关离退休干部服务管理工作。负责机关离退休干部党的建设,承担机关离退休党员干部教育管理监督工作。负责落实机关离退休干部政治、生活待遇,组织开展文化活动。承担机关离退休经费管理工作。指导直属单位离退休干部工作。
Bureau of Retired Officials
Responsibilities: 1. Service management for retired (veteran) cadres. 2. Party committee construction for retired (veteran) cadres, as well as education and administration for retired (veteran) party members and cadres. 3. Put into effect the political status and material amenities of retired (veteran) cadres and organize cultural activities. 4. Funds management for retired (veteran) cadres of NMPA organs. 5. Direct the work relative to retired (veteran) cadres of NMPA directly-affiliated units.
2018年10月16日
(October16, 2018)