| Opinions of the General Office of the State Council on Establishing Professional and Specialist Drug Inspector Teams | | 国务院办公厅关于建立职业化专业化药品检查员队伍的意见 |
| (No. 36 [2019] of the General Office of the State Council) | | （国办发〔2019〕36号） |
| The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under the State Council: | | 各省、自治区、直辖市人民政府，国务院各部委、各直属机构： |
| Professional and specialist drug (including medical devices and cosmetics) inspectors are persons who, as approved by the drug regulatory authorities, conduct compliance confirmation and risk judgment with respect to administratees' places and activities for the development and manufacture of drugs and the like and are an important supporting force to strengthen drug regulation and guarantee drug safety. For the purposes of implementing the decisions and arrangements of the CPC Central Committee and the State Council, establishing professional and specialist drug inspector teams, and further improving drug regulatory systems and mechanisms, with the approval of the State Council, the following opinions are hereby offered. | | 职业化专业化药品（含医疗器械、化妆品）检查员是指经药品监管部门认定，依法对管理相对人从事药品研制、生产等场所、活动进行合规确认和风险研判的人员，是加强药品监管、保障药品安全的重要支撑力量。为贯彻党中央、国务院决策部署，建立职业化专业化药品检查员队伍，进一步完善药品监管体制机制，经国务院同意，现提出以下意见。 |
| I. General requirements | | 一、总体要求 |
| 1. Guiding ideology. Xi Jinping Thought on Socialism with Chinese Characteristics in a New Era shall be the guidance, the spirit of the 19th CPC National Congress and the Second and Third Plenary Sessions of the 19th CPC Central Committee shall be comprehensively implemented, in accordance with the decisions and arrangements of the CPC Central Committee and the State Council with respect to strengthening regulation of drug safety, the laws of scientific regulation shall be followed, the reform of drug regulatory systems and mechanisms shall be deepened, strict prevention at the source, strict regulation in the process, and strict control of risks shall be adhered to, and the supervisory inspection of drug safety shall be enhanced, so as to effectively safeguard the physical health of the public and the safety of use of drugs and medical devices. | | （一）指导思想。以习近平新时代中国特色社会主义思想为指导，全面贯彻落实党的十九大和十九届二中、三中全会精神，按照党中央、国务院关于加强药品安全监管的决策部署，遵循科学监管规律，深化药品监管体制机制改革，坚持源头严防、过程严管、风险严控，强化药品安全监督检查，切实保障人民群众身体健康和用药用械安全。 |
| 2. Primary objectives. A professional direction and specialist and technical requirements will be adhered to, and by the end of 2020, the drug regulatory department of the State Council and the provincial drug regulatory authorities will have basically completed the building of a framework of systems for professional and specialist drug inspector teams. On that basis, through another three to five years' efforts, a framework of professional and specialist drug inspector teams that basically meet regulatory requirements for drugs will be established, professional and specialist drug inspector teams with full-time inspectors as the mainstay, with part-time inspectors as supplements, who are politically competent, of good qualities, of integrity, and efficient, will be further improved, and a working system for supervisory inspection of drugs in which powers and responsibilities are clear, cooperation is smooth, and the coverage is comprehensive will be shaped. | | （二）主要目标。坚持职业化方向和专业性、技术性要求，到2020年底，国务院药品监管部门和省级药品监管部门基本完成职业化专业化药品检查员队伍制度体系建设。在此基础上，再用三到五年时间，构建起基本满足药品监管要求的职业化专业化药品检查员队伍体系，进一步完善以专职检查员为主体、兼职检查员为补充，政治过硬、素质优良、业务精湛、廉洁高效的职业化专业化药品检查员队伍，形成权责明确、协作顺畅、覆盖全面的药品监督检查工作体系。 |
| II. Improving drug inspection systems and mechanisms | | 二、完善药品检查体制机制 |
| 3. Building professional and specialist drug inspector teams at provincial and national levels. The drug regulatory department of the State Council and the provincial drug regulatory authorities shall respectively establish professional and specialist drug inspector teams at national and provincial levels, recruit full-time inspectors who meet the requirements for inspection work, and provide technical support for drug regulatory administrative law enforcement and the like. On that basis, the drug regulatory department of the State Council and the provincial drug regulatory authorities shall focus on strengthening the building of inspector teams in respect of high-risk drugs such as vaccines. | | （三）构建国家和省两级职业化专业化药品检查员队伍。国务院药品监管部门和省级药品监管部门分别建立国家级和省级职业化专业化药品检查员队伍，配备满足检查工作要求的专职检查员，为药品监管行政执法等提供技术支撑。在此基础上，国务院药品监管部门和省级药品监管部门要重点强化疫苗等高风险药品检查员队伍建设。 |
| 4. Strengthening the building of inspection agencies. The building of the drug review, inspection and testing agency of the drug regulatory department of the State Council and the national vaccine inspection agency shall be further strengthened, and the agencies shall be responsible for the routine management of the national professional and specialist drug inspector team. The setup of the inspection agencies of provincial inspection agencies shall be improved, and the agencies shall be responsible for the routine management of provincial professional and specialist drug inspector teams. The drug regulatory department of the State Council shall, as needed for regulatory work, strengthen its force for drug inspection work in key areas in which the pharmaceutical industry is concentrated, and manufacturers of high-risk drugs are clustered, so as to implement key inspection and precision inspection. The provincial drug regulatory authorities shall, as needed for regulatory work, strengthen their force for drug inspection work in areas where drug manufacturers are concentrated, and regions with good conditions may establish inspection branch offices by areas to implement inspection in the vicinity and routine inspection. | | （四）强化检查机构建设。进一步加强国务院药品监管部门药品审核查验机构及国家疫苗检查机构建设，负责国家级职业化专业化药品检查员队伍日常管理。完善省级药品监管部门检查机构设置，负责省级职业化专业化药品检查员队伍日常管理。根据监管工作需要，国务院药品监管部门在药品产业集中、高风险药品生产聚集等重点地区加强药品检查工作力量，实施重点检查和精准检查。省级药品监管部门根据监管工作需要，在药品生产聚集的地区加强药品检查工作力量，有条件的地方可分区域设置检查分支机构，实施就近检查和常态化检查。 |
| 5. Specifying the division of powers of inspection. The drug regulatory department of the State Council shall mainly undertake on-site inspection of the research and development process of drugs, medical devices and special-purpose cosmetics, and compliance inspection of the implementation of the Good Laboratory Practice, the Good Clinical Practice for Drugs, and the Good Clinical Practice for Medical Devices; and undertake overseas on-site inspection of drugs, medical devices, and cosmetics and for-cause inspection of manufacture. The provincial drug regulatory authorities shall mainly undertake on-site inspection of the manufacture process of drugs, medical devices and cosmetics and compliance inspection of the implementation of the relevant good manufacture practice; undertake on-site inspection of wholesalers, retail chain headquarters, and third-party platforms for Internet sale of drugs; and guide city and county market regulatory authorities in on-site inspection of distribution and use of drugs, medical devices, and cosmetics and compliance inspection of the implementation of the relevant good distribution practice. Drug inspection matters shall be classified under central or local fiscal powers according to the affiliation of functional departments charged with duties, and the fiscal authorities at the same level shall assume responsibility for expenditure. | | （五）明确检查事权划分。国务院药品监管部门主要承担药品、医疗器械、特殊用途化妆品研发过程现场检查，以及药物非临床研究质量管理规范、药物临床试验质量管理规范、医疗器械临床试验质量管理规范执行情况合规性检查；承担药品、医疗器械、化妆品境外现场检查以及生产环节重大有因检查。省级药品监管部门主要承担药品、医疗器械、化妆品生产过程现场检查，以及有关生产质量管理规范执行情况合规性检查；承担药品批发企业、零售连锁总部、互联网销售第三方平台相关现场检查；指导市县级市场监管部门开展药品、医疗器械、化妆品经营、使用环节现场检查，以及有关经营质量管理规范执行情况合规性检查。药品检查事项按照承担职责的职能部门隶属关系分别明确为中央或地方财政事权，由同级财政部门承担支出责任。 |
| The inspection of high-risk drugs such as vaccines shall be further strengthened. The drug regulatory department of the State Council shall strengthen unannounced inspection and overseas inspection of the development and manufacture of high-risk drugs such as vaccines, conduct visitation from time to time, strengthen random inspection. The provincial drug regulatory authorities shall be directly responsible for resident inspection and routine inspection of the manufacture process of high-risk drugs such as vaccines, implement more centralized and stricter on-site inspection, public disclosure of information, and adverse reaction monitoring reports, and other systems, and conduct strict territorial regulation. | | 进一步加强疫苗等高风险药品检查工作。国务院药品监管部门强化疫苗等高风险药品研制、生产环节的飞行检查以及境外检查，不定期开展巡查并加强随机抽查。省级药品监管部门直接负责疫苗等高风险药品生产过程的派驻检查、日常检查，落实更加集中、更加严格的现场检查、信息公示、不良反应监测报告等制度，实行严格的属地监管。 |
6. Implementing inspection requirements. The drug regulatory department of the State Council and the provincial drug regulatory authorities shall develop and improve the rules and procedures for drug inspection work and strengthen various inspection work. The drug regulatory department of the State Council and the provincial drug regulatory authorities shall further strengthen the management of quality safety risks to drugs in the whole process, comprehensively implement regulation by "random selection of subjects and inspectors and public disclosure" in thematic inspection, unannounced inspection and other work, and accelerate the advancement of smart drug regulation based on cloud computing, big data, "Internet plus" and other information technologies to improve the effectiveness of supervisory inspection. The drug regulatory department of the State Council and the provincial drug regulatory authorities shall accelerate the improvement of the internal informant system. Drug inspector teams shall implement requirements for on-site inspection for drug registration, resident inspection of vaccine drugs, territorial inspection and overseas inspection, vigorously cooperate in handling drug regulatory and audit cases, comply with requirements for for-cause inspection, and provide technical support for scientific supervision and lawful investigation and punishment of drug-related illegal acts.
．．．．．． | | （六）落实检查要求。国务院药品监管部门和省级药品监管部门要制定完善药品检查工作规则和流程规范，强化各项检查工作。进一步加强药品全过程质量安全风险管理，专项检查、飞行检查等工作要全面推行“双随机、一公开”监管，加快推进基于云计算、大数据、“互联网＋”等信息技术的药品智慧监管，提高监督检查效能。加快完善内部举报人制度。药品检查员队伍要落实药品注册现场检查、疫苗药品派驻检查以及属地检查、境外检查要求，积极配合药品监管稽查办案，落实有因检查要求，为科学监管、依法查办药品违法行为提供技术支撑。
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