我国药物临床试验机构监督检查现状分析  

Analysis of the Status of Supervision and Inspection of Drug Clinical Trial Institutions in China

作　　者：陈夏燕 李会娟[2] CHEN Xia-yan;LI Hui-juan(Peking University First Hospital;Clinical Research Institute,Institute of Advanced Clinical Medicine,Peking University)

机构地区：[1]北京大学第一医院 [2]北京大学临床医学高等研究院,临床研究所

出　　处：《中国食品药品监管》2025年第3期82-91,共10页China Food & Drug Administration Magazine

基　　金：首都卫生发展科研专项(首发2022-2G-4253)。

摘　　要：目的:分析我国药物临床试验机构监督检查现状,比较各地区监管执行情况,梳理监督检查结果,为新规落地与监管体系优化提供参考。方法:检索2019年6月16日~2023年11月9日在药物临床试验机构备案管理信息平台上登记的监督检查信息,统计分析各地区监督检查类型、次数、频率和结果。结果:8%(128/1652)的新机构或新增专业首次监督检查要求取消备案;3%(4/119)的地址变更检查不通过。日常监督检查中,59%(1143/1929)要求整改或已整改,5%(89/1929)要求限期整改,3%(65/1929)不通过。其他检查中,4%(9/217)要求限期整改,5%(10/217)不通过或取消备案。结论:2019年以来,我国大部分地区逐步定期对行政区域内的药物临床试验机构开展了监督检查。然而,本研究发现部分地区存在监督检查频率较低、信息公开程度较低或不及时等问题。新机构或新增专业首次监督检查受研究者资质要求限制,日常监督检查普遍发现药物临床试验机构在制度规程修订及运行、人员培训和场所与设施设备等方面存在不足。未来应在新发布的《药物临床试验机构监督检查办法(试行)》指导下,统一监督检查工作,并进一步探索基于风险的监督检查制度,增加监管透明性。Objective:This study aims to analyze the current status of supervision and inspection of drug clinical trial institutions across China,compare regulatory implementation across different regions,summarize supervision and inspection results,and provide insights for the implementation of new regulations and the optimization of the regulatory system.Methods:Information on inspections recorded on the Drug Clinical Trial Institution Record-Keeping Management Information Platform between June 16,2019,and November 9,2023,was retrieved and analyzed.The study assessed the types,frequencies,and outcomes of inspections across different regions.Results:Among first-time inspections for new institutions/specialties,8%(128/1652)resulted in the cancellation of registration,while 3%(4/119)of address change inspections failed.In routine inspections,59%(1143/1929)required to rectify or have rectified,5%(89/1929)required rectification within a specified period,and 3%(65/1929)either failed or had their registration canceled.Among other types of inspections,4%(9/217)required rectification within a specified period,and 5%(10/217)either failed or had their registration canceled.Conclusion:Since 2019,most regions in China have gradually carried out regular inspections of drug clinical trial institutions.However,this study identified several challenges,including low inspection frequency in certain areas,inconsistencies in inspection standards,limited transparency,and delays in information disclosure.First-time inspections for new institutions/specialties were often affected by researcher qualification requirements,while routine inspections frequently revealed deficiencies in the revision and implementation of institutional protocols,personnel training,and the management of facilities and equipment.Moving forward,efforts should align with the newly enacted Measures for the Supervision and Inspection of Drug Clinical Trial Institutions(Trial Implementation)to standardize supervision and inspection procedures,explore risk-based inspection mod

关 键 词：监督检查 药物临床试验 机构 监管 数据分析 

分 类 号：R95[医药卫生—药学]