Article(id=1292135458172072857, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.11.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1774972800000, receivedDateStr=2026-04-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998699944, onlineDateStr=2026-08-06, pubDate=1781625600000, pubDateStr=2026-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998699944, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998699944, creator=13701087609, updateTime=1785998699944, updator=13701087609, issue=Issue{id=1292135402790482407, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1781625600000', pubDateStr='2026-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1785998686739, creator='13701087609', updateTime=1786014315540, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292200954833686587, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292200954833686588, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1624, endPage=1630, ext={EN=ArticleExt(id=1292135458419536794, articleId=1292135458172072857, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis on classification review procedure and communication work of advanced therapy medicinal products by the European Medicines Agency, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Advanced therapy medicinal products (ATMPs), as a cutting-edge frontier in the current biomedical sector, hold enormous potential to address unmet clinical medical needs. Nevertheless, such products are confronted with multiple challenges including high technical complexity, distinctive research and development risks and substantial investment costs. Their accurate classification and scientific regulation are critical to advancing the standardized development of the industry. Over years of practical experience, the European Medicines Agency (EMA) has established a robust legal and regulatory system, accompanied by a series of issued guidelines, thus forming a relatively mature regulatory framework. Furthermore, relying on the Committee for Advanced Therapies (CAT), the EMA has developed a comprehensive mechanism for the classification, designation, and communication of ATMPs, which serves as an important reference for the global regulation of ATMPs. This paper systematically elaborates on the classification criteria and designation procedures of ATMPs formulated by the EMA, and introduces its practical communication practices, including scientific advice and innovation task force briefings. This paper provides insights and references for improving China’s ATMP classification management system, optimizing the evaluation and communication mechanism, and constructing a scientific and efficient regulatory framework.

, authors=Fan ZHANG, Yu-tao WANG, Yun-rui DI, Jun WANG, authorsList=Fan ZHANG, Yu-tao WANG, Yun-rui DI, Jun WANG, authorCompany=null, correspAuthors=Jun 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=1292135458721526683, articleId=1292135458172072857, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=欧洲药品管理局先进治疗药物分类认定及沟通交流工作情况分析, 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=

先进治疗药物（ATMPs）作为当今生物医药领域的前沿阵地，在解决未被满足的临床需求方面展现出了巨大潜力。然而，这类产品同时面临着技术复杂度高、研发风险特殊、投入成本较高等挑战，其精准的分类与科学的监管是推动产业高质量发展的关键。欧洲药品管理局（EMA）在多年的实践中建立了完善的法律法规体系，配套发布了一系列指导原则，搭建了相对成熟的监管框架体系。此外，依托先进治疗委员会（CAT），EMA建立了先进治疗药物分类认定与沟通交流机制，为全球先进治疗药物监管提供了重要借鉴。本文详细梳理了EMA对ATMPs的分类界定标准与认定程序，介绍了其科学建议、创新工作组简报会议等沟通交流工作实践，为完善我国先进治疗药物分类管理制度、优化审评沟通机制、构建科学高效的监管体系提供参考。

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品政策法规相关工作

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张帆（1990-），女，主管药师，主要从事药品审评项目管理与药品政策法规相关工作

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