Article(id=1292135575180571367, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.019, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777219200000, receivedDateStr=2026-04-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998727840, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998727840, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998727840, creator=13701087609, updateTime=1785998727840, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1469, endPage=1473, ext={EN=ArticleExt(id=1292135575352537832, articleId=1292135575180571367, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=A preliminary analysis of the new requirements in ICH E6 (R3) from a verification perspective and their implications for clinical trial verification, columnId=1292126496848638045, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Regulatory Science Column, runingTitle=null, highlight=null, articleAbstract=

The evolution of the ICH E6(R3) guideline heralds a new era for global Good Clinical Practice (GCP), centered on "participant-centricity" and "Quality by Design". From the perspective of China′s clinical trial regulatory inspection, this article provides a systematic comparative analysis of the transformative changes introduced by E6(R3) versus E6(R2) across seven key dimensions: core principles, trial design, ethical review, safety monitoring, vendor management, sponsor quality management, and data governance. The study concludes that these changes necessitate a fundamental paradigm shift in China′s registration inspection approach—moving from traditional "compliance verification" to an in-depth "assessment of system effectiveness" and "design rationality". To address this challenge, regulatory authorities must take the lead in comprehensively upgrading inspection philosophies, inspector competencies, technical tools, and evaluation standards. This will guide the clinical trial ecosystem in China towards high-quality and sustainable development, ensuring the effective protection of participants′ rights, safety, and welfare.

, authors=Yuan WANG, Yu-yao WANG, Rong GAO, authorsList=Yuan WANG, Yu-yao WANG, Rong GAO, authorCompany=null, correspAuthors=Rong GAO, 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=1292135575629361897, articleId=1292135575180571367, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于核查视角浅析ICH E6（R3）的新要求及其对临床试验核查的启示, columnId=1292126497112879199, journalTitle=中国临床药理学杂志, columnName=药物监管科学专栏, runingTitle=null, highlight=null, articleAbstract=

国际人用药品注册技术协调会（ICH）E6（R3）指导原则在不断演进，这不仅仅是一个简单的版本更新，更标志着全球药物临床试验质量管理规范（GCP）已然迈入了一个崭新的时代，这个时代的核心在于坚持“以试验参与者为中心”以及贯彻“质量源于设计”的理念。本文立足于核查中心在开展临床试验核查工作的具体视角，针对E6（R3）相较于E6（R2）所带来的变革，从试验参与者保护、核心理念、伦理审查、安全性监测、服务供应商管理、申办者质量管理以及数据治理这七大关键维度，进行了系统性的对比与深入剖析。上述这些变革要求我国的注册核查要进行转型：从传统的、侧重于“依从性符合核查”的模式，转向对“体系有效性”与“设计合理性”开展深度评估的新模式。为了能够从容应对这一新模式，监管机构须在核查理念的更新、检查员能力的培养、技术工具的运用以及评价标准的制定上，率先去进行全面的升级。如此一来，方能引导我国临床试验生态体系实现高质量且可持续的发展，从而切实地去保障试验参与者的权益、安全与福祉。

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