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Announcement of the National Medical Products Administration on Issuing the Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation) | | 国家药监局关于发布《药物临床试验机构监督检查办法(试行)》的通告 |
(Announcement No. 56 [2023] of the National Medical Products Administration) | | (国家药品监督管理局通告2023年第56号) |
To further strengthen the administration of clinical drug trial institutions and regulate the supervision and inspection of drug clinical trial institutions, the National Medical Products Administration has organized the development of the Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation), which are hereby issued. | | 为进一步加强对药物临床试验机构的管理,规范药物临床试验机构监督检查工作,国家药监局组织制定了《药物临床试验机构监督检查办法(试行)》,现予发布。 |
This Announcement shall come into force on March 1, 2024. | | 本通告自2024年3月1日起实施。 |
| | 特此通告。 |
Annex: Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation) | | 附件:药物临床试验机构监督检查办法(试行) |
National Medical Products Administration | | 国家药监局 |
November 3, 2023 | | 2023年11月3日 |
Annex | | 附件 |
Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation) | | 药物临床试验机构监督检查办法(试行) |
Chapter I General Provisions | | 第一章 总 则 |
Article 1 These Measures are developed in accordance with the Pharmaceutical Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, the Provisions on the Administration of Drug Clinical Trial Institutions, and the Good Clinical Practice for Drugs (“GCP”) to regulate the supervision and inspection of drug clinical trial institutions and strengthen the administration of drug clinical trials. | | 第一条 为规范药物临床试验机构监督检查工作,加强药物临床试验管理,根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》以及《药品注册管理办法》《药物临床试验机构管理规定》《药物临床试验质量管理规范》(以下简称GCP)等,制定本办法。 |
Article 2 These Measures shall apply to drug regulatory authorities' inspection and handling of the recordation of drug clinical trial institutions (“trial institutions”) and the compliance of drug clinical trial activities carried out for the purpose of drug registration with relevant laws and regulations, the implementation of the GCP, and other circumstances. | | 第二条 药品监督管理部门对药物临床试验机构(以下简称试验机构)备案及开展以药品注册为目的的药物临床试验活动遵守相关法律法规、执行GCP等情况实施检查、处置等,适用本办法。 |
Article 3 The National Medical Products Administration (“NMPA”) shall be responsible for developing the rules for the supervision and inspection of trial institutions, guiding provincial drug regulatory authorities (“provincial authorities”) to carry out the supervision and inspection of trial institutions, and organizing the supervision and inspection of trial institutions as needed. The Center for Food and Drug Inspection of NMPA (“CFDI”) shall be responsible for establishing a national database of inspectors and conducting inspector training and management and carrying out the inspection of trial institutions and drug registration inspection organized by the NMPA; promoting the information technology development of the recordation administration of trial institutions and the supervision and inspection work; assessing the quality management systems of provincial drug inspection institutions and providing technical guidance for the inspection work of all provinces. | | 第三条 国家药品监督管理局(以下简称国家局)负责制定试验机构监督检查制度,指导省级药品监督管理部门(以下简称省级局)开展试验机构监督检查,根据需要组织对试验机构进行监督检查。国家局食品药品审核查验中心(以下简称国家局核查中心)负责建立国家检查员库并实施检查员培训与管理,负责实施国家局组织开展的试验机构检查、药品注册核查;推进试验机构备案管理信息化及监督检查工作信息化建设;对省级药品检查机构质量管理体系进行评估,对各省检查工作进行技术指导。 |
Article 4 Provincial authorities shall be responsible for the supervision and inspection of trial institutions within their respective administrative regions and relevant matters assigned by the NMPA, establishing a working system and mechanism for the supervision and inspection of trial institutions, assigning a provincial team of inspectors matching the inspection of trial institutions in their respective provinces; promoting the information technology development of the supervision and inspection work; organizing the routine supervision and inspection, for-cause inspection, and other inspection of trial institutions within their respective administrative regions, supervising trial institutions' compliance with statutory requirements; and legally punishing any suspected violation of law or regulation committed by trial institutions within their respective administrative regions. | | 第四条 省级局负责本行政区域内试验机构的监督检查以及国家局交办的有关事项,建立试验机构监督检查工作制度和机制,配备与本省试验机构检查工作相匹配的省级检查员队伍;推进监督检查工作信息化建设;组织对本行政区域内试验机构开展日常监督检查、有因检查、其他检查等,监督试验机构符合法定要求;对本行政区域内试验机构涉嫌违法违规行为依法进行处置。 |
Article 5 A drug inspection institution set up by the drug regulatory department shall carry out inspections of trial institutions in accordance with the law, and drug testing, evaluation, and other relevant institutions shall provide technical support as required for the inspection of trial institutions. | | 第五条 药品监督管理部门设置的药品检查机构依法开展试验机构检查,药品检验、审评等机构根据试验机构检查工作需要提供技术支撑。 |
Article 6 A trial institution and its researchers shall effectively fulfill their responsibilities relating to drug clinical trials, and shall, when authorizing other personnel to undertake clinical trial-related work, establish corresponding management procedures, take measures to carry out quality management and strengthen the relevant information technology development. Researchers shall supervise all authorized personnel in carrying out clinical trials in accordance with the applicable laws and regulations, implement trial plans, perform their work duties, protect the rights and interests and safety of human subjects, and guarantee the veracity, accuracy, completeness, and reliability of trial data and results. | | 第六条 试验机构和研究者应当切实履行药物临床试验相关责任,授权其他人员承担临床试验有关工作时,应当建立相应管理程序,并采取措施实施质量管理,加强相关信息化建设。研究者应当监督所有授权人员依法依规开展临床试验,执行试验方案、履行工作职责,保护受试者的权益和安全,保障试验数据和结果真实、准确、完整、可靠。 |
Article 7 According to the nature and purposes of inspections, the inspections of trial institutions are classified into routine supervision and inspection, for-cause inspection, and other inspections. Different types of inspections may be conducted in combination. | | 第七条 根据检查性质和目的,对试验机构开展的检查分为日常监督检查、有因检查、其他检查。不同类型检查可以结合进行。 |
(1) Routine supervision and inspection means the supervision and inspection conducted in accordance with annual inspection plans on trial institutions' compliance with relevant laws and regulations, implementation of the GCP, and rectification of problems found in previous inspections, among others. Routine supervision and inspection shall be carried out based on risks and in light of the conditions of clinical trial projects under research by trial institutions. For the first supervision and inspection after recordation, emphasis shall be placed on verifying the recordation conditions of trial institutions or trial specialties. | | (一)日常监督检查是按照年度检查计划,对试验机构遵守有关法律法规、执行GCP情况、既往检查发现问题的整改情况等开展的监督检查。日常监督检查应当基于风险,结合试验机构在研临床试验项目情况开展。对于备案后首次监督检查,重点核实试验机构或者试验专业的备案条件。 |
(2) For-cause inspection means a targeted inspection of specific issues of a trial institution that may have quality and safety risks or clues to major problems of suspected violations of laws and regulations, such as complaints and reports. In the for-cause inspection, a drug inspection institution may directly enter the inspection site to conduct inspections on possible problems without prior notice to the inspected institution. | | (二)有因检查是对试验机构可能存在质量安全风险的具体问题或者投诉举报等涉嫌违法违规重要问题线索的针对性检查。有因检查可以不提前通知被检查机构,直接进入检查现场,针对可能存在的问题开展检查。 |
(3) Other inspections means inspections other than the aforesaid two types of inspections, such as special inspection and supervision and random inspection. | | (三)其他检查是除上述二种类型检查之外的检查,如专项检查、监督抽查等。 |
Chapter II Drug Inspection Institutions and Their Staff | | 第二章 药品检查机构和人员 |
Article 8 A drug inspection institution shall establish an inspection quality management system, improve inspection work procedures, specify inspection standards and principles, and guarantee the inspection work quality; strengthen the management of inspection records and relevant documents and archives, regularly conduct retrospective analysis of the inspection work, and continuously improve the inspection of trial institutions. | | 第八条 药品检查机构应当建立检查质量管理体系,完善检查工作程序,明确检查标准和原则,保障检查工作质量;加强检查记录与相关文件档案管理;定期回顾分析检查工作情况,持续改进试验机构检查工作。 |
Article 9 A drug inspection institution shall organize and implement inspection tasks according to the inspection plan. The annual plan for routine supervision and inspection of trial institutions shall be made by the provincial authority in light of the specific circumstances of trial institutions and trial activities within its administrative region. The focus of inspection may be selected based on risks and the inspection shall focus on key fields and critical links. | | 第九条 药品检查机构按照检查计划组织实施检查任务。试验机构日常监督检查年度计划由省级局结合本行政区域内试验机构和试验活动的具体情况组织制定;检查可以基于风险选择重点内容,聚焦重点领域、关键环节。 |
Any trial institution, trial specialty, or researcher that falls under any of the following circumstances shall be taken as the focus of inspection or be subject to inspection with increased frequency: | | 对试验机构、试验专业或者研究者存在以下情形的,应当纳入检查重点或者提高检查频次: |
(1) It or he has serious non-compliance problems in the past. | | (一)既往存在严重不合规问题的; |
(2) The researcher undertakes a large number of clinical trial projects at the same time or lacks management ability or the number of researchers is insufficient, among others, which may affect the trial quality. | | (二)研究者同期承担临床试验项目较多、研究者管理能力或者研究人员数量相对不足等可能影响试验质量的; |
(3) There are complaints, reports, or other clues indicating the existence of quality and safety risks. | | (三)投诉举报或者其他线索提示存在质量安全风险的。 |
Article 10 Inspectors shall have corresponding inspection qualification and ability; strictly abide by laws and regulations, integrity disciplines and work requirements, and shall not raise requirements irrelevant to inspection to the inspected institution. They shall receive integrity education before the inspection and sign a letter of commitment and a statement on no conflicts of interest; and voluntarily make statements and withdraw from the inspection if they have any interest in the inspected institution or fall under any other circumstance which may affect the impartiality of inspection results. | | 第十条 检查人员应当具备相应的检查资质和能力;应当严格遵守法律法规、廉政纪律和工作要求,不得向被检查机构提出与检查无关的要求;在检查前应当接受廉政教育,签署承诺书和无利益冲突声明;与被检查机构存在利益关系或者有其他可能影响检查结果公正性的情况时,应当主动声明并回避。 |
Article 11 Inspectors shall strictly abide by the provisions on confidentiality and sign confidentiality agreements, strictly manage confidential materials, and strictly prevent the leakage of confidential materials. They shall not divulge any information relating to the inspection or technical or trade secrets of the inspected institution. | | 第十一条 检查人员应当严格遵守保密规定并签署保密协议,严格管理涉密资料,严防泄密事件发生。不得泄露检查相关信息及被检查机构技术或者商业秘密等信息。 |
Chapter III Inspection Procedures | | 第三章 检查程序 |
Article 12 Before an inspection, a drug inspection institution shall make a specific inspection plan according to inspection tasks, specifying the inspection content, time, and methods, among others. The method of on-site inspection shall be mainly adopted for inspection, and remote inspection may be conducted as the case may be. | | 第十二条 实施检查前,药品检查机构应当根据检查任务制定具体检查方案,明确检查内容、检查时间和检查方式等。检查方式以现场检查为主,可视情况开展远程检查。 |
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