Article(id=1322624495215554929, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.19.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1781884800000, receivedDateStr=2026-06-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793267852833, onlineDateStr=2026-10-29, pubDate=1791993600000, pubDateStr=2026-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793267852833, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793267852833, creator=13701087609, updateTime=1793267852833, updator=13701087609, issue=Issue{id=1322624482217415197, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='19', pageStart='2017', pageEnd='2128', issueExtLink='null', onlineDate='null', pubDate='1791993600000', pubDateStr='2026-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1793267849735, creator='13701087609', updateTime=1793268229475, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322626075042100008, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322626075046294313, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322624482217415197, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2038, endPage=2047, ext={EN=ArticleExt(id=1322624495412687218, articleId=1322624495215554929, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Key changes in the 2026 edition of the Good Clinical Practice regarding safety reviews and corresponding measures, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

AbstractThe new edition of the Good Clinical Practice (GCP) was officially issued on June 8, 2026. It fully incorporates the core principles of the ICH guideline E6(R3): Guideline for Good Clinical Practice and fundamentally reshapes the clinical trial safety review system. Through a comparative analysis of the 2026 and 2020 versions of the GCP, and with reference to supporting documents such as the Technical Guidance on the Collection, Analysis, and Reporting of Expedited Safety Reports by Sponsors During Clinical Trials (Draft for Comment) (2026), this study provides an in-depth analysis of the key changes and underlying logic of the safety review under the new regulations. The study concludes that the new regulations comprehensively introduce the concept of “risk-proportionality,” further optimizing the safety reporting mechanism, the content of safety reviews, and the approaches of safety review, while clarifying the responsibilities of relevant parties. To adapt to these changes, safety reviews under the new regulations should establish an ethics review system aligned with the new requirements by strengthening the review capabilities of ethics committee members, optimizing review procedures, refining the content and requirements of safety reviews, and enhancing multi-stakeholder collaboration.

, authors=Man GAO¹, Xue-qing PENG¹, Kai-hui WU¹, Ji-yin ZHOU^{2, *}, authorsList=Man GAO, Xue-qing PENG, Kai-hui WU, Ji-yin ZHOU, authorCompany=null, correspAuthors=Ji-yin ZHOU, 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=1322624495681122675, articleId=1322624495215554929, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=《药物临床试验质量管理规范》2026年版对安全性审查的重点变化及应对举措, columnId=1322624486113915175, journalTitle=中国新药杂志, columnName=·2026年版《药物临床试验质量管理规范》解读专题, runingTitle=null, highlight=null, articleAbstract=

新版《药物临床试验质量管理规范》于2026年6月8日正式发布，全面吸纳国际ICH《E6（R3）：药物临床试验质量管理规范技术指导原则》的核心原则，对临床试验安全性审查体系进行了根本性重塑。通过对《药物临床试验质量管理规范》2026年版与《药物临床试验质量管理规范》2020年版进行比对性审视，参考《申办者临床试验期间安全性快速报告的信息收集、分析与报告技术指导原则（征求意见稿）》（2026年）等配套文件，深入剖析新规安全性审查的重点变化和内在逻辑。研究认为，新规全面引入“风险相称”理念，对安全性报告机制、安全性审查内容、安全性审查方式进一步优化，并明确相关方责任。为适应上述变化，新规下安全性审查应从加强伦理审查委员会委员审查能力建设、优化审查流程、完善安全性审查内容和要求以及加强多方协同合作4个方面构建适配新要求的伦理审查体系。

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高漫，女，主管药师，主要从事临床试验与医学伦理研究。E-mail: 110702867@qq.com。

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orderNo=3, keyword=伦理审查委员会), Keyword(id=1322624502861771158, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, language=CN, orderNo=4, keyword=风险管理)], refs=[Reference(id=1322624503360893337, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［1］, rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The ICH E6(R3) Guideline reaches Step 4 of the ICH Process.(2025-01-14)[2026-06-23].https://www.ich.org/news/ich-e6r3-guideline-reaches-step-4-ich-process., articleTitle=null, refAbstract=null), Reference(id=1322624503646106010, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［2］, rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=国家药品监督管理局, 国家卫生健康委员会, 国家中医药管理局. 国家药监局、国家卫生健康委、国家中医药局、国家疾控局关于发布药物临床试验质量管理规范的公告（2026年第50号）.(2026-06-08)[2026-06-10].https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20260608103856150.html., articleTitle=null, refAbstract=null), Reference(id=1322624503738380699, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［3］, rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=张亚美, 何芹, 周吉银. 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AI赋能科技伦理审查——全球首个伦理审查智能体“一鉴”亮相2025世界人工智能大会.(2025-07-27)[2026-06-09].https://mp.weixin.qq.com/s/ht_S9d6Ywj8NFqwI3JaTtA., articleTitle=null, refAbstract=null), Reference(id=1322624504937951648, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=［8］, rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=浙江省中医院. 数智赋能, 伦理先行——人工智能伦理治理创新与临床研究高质量发展会议举办.(2026-02-05)[2026-06-09].https://mp.weixin.qq.com/s/97a1pQJVnu 3SI8_UKZnLTw., articleTitle=null, refAbstract=null)], funds=[Fund(id=1322624503230869911, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322624495215554929, awardId=2025ZD266, language=CN, fundingSource=常德市科技创新指导性计划资助项目(2025ZD266), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322624495890837876, tenantId=1146029695717560320, 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