Article(id=1292126489168863961, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.03.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1758470400000, receivedDateStr=2025-09-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996561567, onlineDateStr=2026-08-06, pubDate=1771257600000, pubDateStr=2026-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996561567, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996561567, creator=13701087609, updateTime=1785996561567, updator=13701087609, issue=Issue{id=1292126460546929080, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1771257600000', pubDateStr='2026-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996554742, creator='13701087609', updateTime=1786014541627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201903060963536, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201903060963537, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=439, endPage=444, ext={EN=ArticleExt(id=1292126489533768410, articleId=1292126489168863961, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of safety risks and regulatory responses during drug clinical trials, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=
Objective To provide practical references for all participants in drug clinical trials on drug safety risk management and promote the construction of a more efficient clinical trial safety management system.
Methods Based on the regulatory practice of 40 clinical trial safety risk control cases from the Center for Drug Evaluation in 2024, this paper uses classified statistics and correlation analysis methods to analyze the characteristics of safety risk information from multiple dimensions such as drug types and indications, and systematically sorts out the response logic of regulatory measures.
Results Among the 40 cases where risk management procedures were initiated, distinct risk characteristics were observed across different drug types and indications. The regulatory measures reflected the principle of matching the intensity of control with the risk characteristics.
Conclusion Regulatory authorities have adopted differentiated regulatory requirements in accordance with the logic of risk classification and bottom-line thinking. The regulatory initiatives have gradually evolved into focusing on the optimization and full-chain improvement of sponsors’ risk management systems, providing crucial support for the protection of subjects’ rights and interests as well as the high-quality development of pharmaceutical innovation..
, authors=Wen-ya TANG, Min LIU, Feng XUE, Hai-xue WANG, authorsList=Wen-ya TANG, Min LIU, Feng XUE, Hai-xue WANG, authorCompany=null, correspAuthors=Hai-xue WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126489756066523, articleId=1292126489168863961, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=药物临床试验期间安全性风险及监管响应分析, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=
目的 为药物临床试验各参与方提供药物安全性风险管理的实践参考，推动构建更高效的临床试验安全性管理体系。
方法 本文以2024年药审中心40次临床试验安全风险控制案例的监管实践为数据基础，采用分类统计与关联分析方法，从药物类型、适应症等多维度解析安全性风险信息的特征，系统梳理监管措施的响应逻辑。
结果 在启动风险管控程序的40个案例中，不同药物类型、不同适应症呈现出差异化的风险特征，监管举措体现了管控强度与风险特征相匹配的原则。
结论 监管机构遵循风险分级管控逻辑和底线思维，提出差异化的监管要求，监管举措逐步升级为聚焦申办者风险管理体系的优化与全链条完善，为受试者权益保护与医药创新高质量发展提供重要支撑。
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唐文雅（1988-），女，高级工程师，主要从事药物临床试验安全风险管理与药物警戒工作
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