Article(id=1321425639719157913, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425597998420385, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.08.004, 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=1792982023410, onlineDateStr=2026-10-26, pubDate=1777478400000, pubDateStr=2026-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982023410, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982023410, creator=13701087609, updateTime=1792982023410, updator=13701087609, issue=Issue{id=1321425597998420385, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='8', pageStart='785', pageEnd='896', issueExtLink='null', onlineDate='null', pubDate='1777478400000', pubDateStr='2026-04-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982013463, creator='13701087609', updateTime=1792983113439, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430211678290797, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425597998420385, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430211678290798, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425597998420385, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=812, endPage=818, ext={EN=ArticleExt(id=1321425641510125722, articleId=1321425639719157913, 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 I): the core content of global competency framework for regulators of medicines and guidelines for advancing smart regulation, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

As a specialized agency of the United Nations, the World Health Organization (WHO) is dedicated to promoting the effective regulation of medical products across countries, ensuring that medicines, vaccines, and medical devices can sustain the normal functioning of national health systems and enable individuals from different countries to access high-quality health support. Since 2014, WHO has launched the regulatory systems strengthening (RSS) program for medical products, adopting a series of initiatives to develop a comprehensive framework that guides countries in enhancing their medical product regulatory capacities and provides crucial support for the coordinated improvement of regulatory capabilities on a global scale. This paper focuses on explaining the core initiatives under the RSS program, including the quality management system (QMS), good regulatory practices (GRP), good reliance practices (GRelP), and global competency framework (GCF), which is expected to provide references and insights to accelerate the modernization of drug administration and enhance the international competitiveness of the pharmaceutical industry in China.

, 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=1321425641908584603, articleId=1321425639719157913, 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（上）——全球药品监管能力框架与促进智慧监管指导原则的核心内容, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

作为联合国下设机构，WHO致力于推动各国对医疗产品实施有效监管，以此确保药品、疫苗和医疗器械能够助力国家健康体系正常运转，使来自不同国家的个体都能获得高水平的健康保障。2014年以来，WHO启动医疗产品监管系统加强计划，通过系列举措构建系统解决方案，为全球范围内监管能力的协同发展提供了重要支撑。本文着重阐释了该计划框架下的核心举措，涵盖质量管理体系、良好监管实践、良好信赖实践、全球药品监管机构能力框架等方面，旨在为我国药品监管机构加快推进中国式药品监管现代化、提升医药产业国际竞争力提供借鉴与参考。

, 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=gBhlf3fgZVjySRynLyk67A==, magXml=XCDCXeHPKzzPOsU1tnlfEw==, pdfUrl=null, pdf=mJ03sNpavmIkct9ggRa2Qw==, pdfFileSize=5871808, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=2SWdYuleEbVYx7UyHc8vwA==, mapNumber=null, fund=null)}, authors=[Author(id=1321425642751639715, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425639719157913, 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=1321425642848108710, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425639719157913, authorId=1321425642751639715, 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
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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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