Article(id=1291404942628090061, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404807152067353, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.08.026, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1732118400000, receivedDateStr=2024-11-21, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824531466, onlineDateStr=2026-08-04, pubDate=1745769600000, pubDateStr=2025-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824531466, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824531466, creator=13701087609, updateTime=1785824531466, updator=13701087609, issue=Issue{id=1291404807152067353, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1745769600000', pubDateStr='2025-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824499166, creator='13701087609', updateTime=1785824499166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1196, endPage=1200, ext={EN=ArticleExt(id=1291404942804250830, articleId=1291404942628090061, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Overview of the international medicines agencies real world research action plan, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

This study examines the practical value of regulatory science action plans in identifying strategic regulatory trends. By analyzing real-world research initiatives from leading international drug regulatory agencies through three dimensions—data platform development, regulatory science implementation, and international harmonization—this paper provides critical references for researchers and regulatory practitioners. Internationally, regulatory authorities have established robust data platforms such as Sentinel, DARWIN EU, and MID-NET. Collaborative partnerships with academic institutions have been formed to advance frontier research topics, while concerted efforts toward international coordination aim to standardize real-world evidence (RWE) applications. Current technical priorities focus on innovations in data infrastructure and research paradigms, particularly methodological advancements in bias mitigation and causal inference frameworks. The expanding application of RWE across the entire drug lifecycle marks a pivotal trend in global pharmaceutical regulation. These developments offer strategic insights for China to accelerate the construction of integrated data platforms and cultivate an innovation-driven regulatory ecosystem.

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关注药品监管机构监管科学行动计划对把握监管战略动向具有很高实操价值。本文从数据平台建设、监管科学行动、国际协调3个维度，梳理全球先进监管机构的真实世界研究行动计划与技术关注热点，为研究人员及监管人员提供参考。国际药品监管机构先后建立了Sentinel、DARWIN EU及MID-NET等数据平台，同时通过与学术机构合作开展课题研究前沿课题，并注重国际协调促进真实世界证据的标准化应用。在前沿课题中关注的技术热点多聚焦数据平台与研究范式创新，关注因果推断的偏倚控制与框架化。真实世界证据的应用逐步扩展至药物全生命周期管理，成为全球药品监管的重要趋势，为中国构建数据平台和创新生态的战略布局提供参考。

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赵骏（1990-），男，助理研究员，主要从事新药生物统计学评价的相关研究

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赵骏（1990-），男，助理研究员，主要从事新药生物统计学评价的相关研究

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