Article(id=1321425692022124841, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1768147200000, acceptedDateStr=2026-01-12, onlineDate=1792982035880, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982035880, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982035880, creator=13701087609, updateTime=1792982035880, updator=13701087609, issue=Issue{id=1321425625915707977, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='9', pageStart='897', pageEnd='1008', issueExtLink='null', onlineDate='null', pubDate='1778774400000', pubDateStr='2026-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982020119, creator='13701087609', updateTime=1792983090252, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430114441745406, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430114441745407, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=924, endPage=931, ext={EN=ArticleExt(id=1321425692420583722, articleId=1321425692022124841, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide (part Ⅱ): key requirements for the global benchmarking tool and the WHO-listed authorities framework, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The WHO launched the regulatory system strengthening program for medical products in 2014, aiming to encourage the enhancement of medical product regulatory levels in countries and promote the coordinated development of regulatory capabilities globally. This initiative encompasses guidelines on quality management systems, good regulatory practices, good trust practices, and a global regulatory capacity framework. Its core tools are the global benchmarking tool (GBT) for regulatory system assessment and the WHO-listed authorities (WLA) framework built upon the GBT. Understanding the assessment requirements of the GBT and WLA can not only provide ideas for improving China's drug regulatory system but also serve as a reference for aligning regulatory work with international standards. This paper systematically introduces the assessment dimensions and key requirements of the GBT and WLA in order to explore their intrinsic relationship with relevant guiding principles.

, authors=Yan-ling ZHANG^{1, 2}, Ming-shu MA², Yi-fei WANG², Rong SHAO^{1, *}, authorsList=Yan-ling ZHANG, Ming-shu MA, Yi-fei WANG, Rong SHAO, authorCompany=null, correspAuthors=Rong SHAO, 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=1321425693674680620, articleId=1321425692022124841, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=浅析WHO促进各国医疗产品监管水平提升的举措与工具（下）——全球基准评估工具和WHO列名机构框架的关键要求, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

WHO于2014年发起医疗产品监管系统加强计划，旨在推动各国提升医疗产品监管水平，促进全球范围内监管能力的协同发展。该计划涵盖质量管理体系、良好监管实践、良好信赖实践等相关指南及全球监管能力框架，其核心工具为用于监管体系评估的全球基准评估工具（global benchmarking tool, GBT）以及基于GBT构建的WHO列名机构（WHO-listed authorities, WLA）框架。理解GBT和WLA的评估要求，不仅可以为我国药品监管体系的完善提供思路，也可以为监管工作与国际接轨提供参考。本文系统介绍GBT与WLA的评估维度及关键要求，以期探讨其与相关指导原则的内在关系。

, authors=张燕玲^{1, 2}, 马茗舒², 王艺霏², 邵蓉^{1, *}, authorsList=张燕玲, 马茗舒, 王艺霏, 邵蓉, authorCompany=null, correspAuthors=邵蓉, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=D0paSbxJdu40imeel66+8A==, magXml=T8M0BtbskwjE2EJzWJXfdw==, pdfUrl=null, pdf=FSlFBg2WfyS51XNB3PHlvQ==, pdfFileSize=4817453, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=LNKZHxbQnhcjmx/UZvxbAg==, mapNumber=null, fund=null)}, authors=[Author(id=1321425696937849141, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425692022124841, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhangyanling1302@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425697378251064, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425692022124841, authorId=1321425696937849141, language=EN, stringName=Yan-ling ZHANG, firstName=Yan-ling, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
²Health China Research Institute, China Health Media Group, Beijing 100082, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425697462137145, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425692022124841, authorId=1321425696937849141, language=CN, stringName=张燕玲, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹中国药科大学国际医药商学院，南京 211198
²中国健康传媒集团健康中国研究院，北京 100082, bio={"content":"

张燕玲，女，博士研究生，主要从事药品监管政策、健康传播研究。联系电话：（010）83025816，E-mail: zhangyanling1302@163.com。

"}, bioImg=null, bioContent=

张燕玲，女，博士研究生，主要从事药品监管政策、健康传播研究。联系电话：（010）83025816，E-mail: zhangyanling1302@163.com。

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