Article(id=1321425576905265454, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.001, 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=1748966400000, acceptedDateStr=2025-06-04, onlineDate=1792982008433, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982008433, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982008433, creator=13701087609, updateTime=1792982008433, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=673, endPage=678, ext={EN=ArticleExt(id=1321425578591375664, articleId=1321425576905265454, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analyzing priority challenges in China's vaccine regulation with the Hanlon method, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To analyze the priority challenges in vaccine regulation in China and provide reference for the improvement of the national regulatory system.
Methods: A list of possible challenges in vaccine regulation in China was generated through literature review and in-depth interviews. Using the Hanlon method, expert consultation was conducted to assess the importance, severity and feasibility of intervention for these potential challenges to screen out priority challenges.
Results: The expert response rate was 83.5%, the expert authority coefficient was 0.772, and the coordination coefficients for expert scoring on the importance, severity, and feasibility of intervention of potential challenges were 0.576, 0.517, and 0.510, respectively (P<0.05). According to the results of the Hanlon's analysis, the top five priority challenges in vaccine regulation in China were: inadequate development of regulatory human resources; an underdeveloped information disclosure and public communication mechanism; an incomplete quality management system within regulatory authorities; weak quality management capabilities in some enterprises; and insufficient coordination in accelerated regulatory processes.
Conclusion: This study suggests that strengthening the development of professional human resources, improving mechanisms for information disclosure and public communication, enhancing quality management system construction, guiding enterprises to implement self-regulation, and coordinating accelerated regulatory mechanisms are five key dimensions for systematically advancing vaccine regulatory capacity and comprehensively improving the level of vaccine regulatory governance in China.
, authors=Ri-zhen WANG
1, Ming XU
1, 2, Hai-long PAN
3, Shu-yan ZUO
3, Yuan YUAN
4, Yang-mu HUANG
1, 2, *, authorsList=Ri-zhen WANG, Ming XU, Hai-long PAN, Shu-yan ZUO, Yuan YUAN, Yang-mu HUANG, authorCompany=null, correspAuthors=Yang-mu HUANG, 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=1321425578868199729, articleId=1321425576905265454, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=基于Hanlon方法分析我国疫苗监管领域的优先挑战, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=
目的： 综合分析我国疫苗监管领域优先挑战，为国家监管体系完善提供参考。
方法： 通过文献回顾和深度访谈形成我国疫苗监管领域的可能挑战清单，使用Hanlon方法对可能挑战的重要性、严重性和干预有效性进行专家咨询，筛选优先挑战。
结果： 专家积极系数为83.5%，专家权威系数为0.772，对可能挑战的重要性、严重性和干预有效性评分的专家协调系数分别为0.576、0.517和0.510（P<0.05）。Hanlon分析结果显示，目前我国疫苗监管领域排名前5位的关键挑战依次为监管人力资源建设有待提升、信息公开和宣传机制尚未完善、监管部门质量管理体系建设尚未完善、部分企业的质量管理能力较弱和疫苗加速监管协调不足。
结论： 本研究结果提示加强专业人才队伍建设、健全信息公开和宣传机制、重视质量管理体系建设、引导企业落实自我监管、协调加速监管机制等5个维度是系统推进疫苗监管能力建设以及全面提升我国疫苗监管治理水平的优先领域。
, authors=王日珍
1, 许铭
1, 2, 潘海龙
3, 左树岩
3, 袁瑗
4, 黄旸木
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1北京大学公共卫生学院全球卫生学系，北京 100191, bio={"content":"
王日珍，女，博士，主要从事疫苗监管相关研究。E-mail: wrz_@stu.pku.edu.cn。
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王日珍，女，博士，主要从事疫苗监管相关研究。E-mail: wrz_@stu.pku.edu.cn。
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1北京大学公共卫生学院全球卫生学系，北京 100191
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3China National Biotec Group Company Limited, Beijing 100024, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425580541727053, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, authorId=1321425580415897930, language=CN, stringName=潘海龙, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3中国生物技术股份有限公司，北京 100024, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425579304407352, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, xref=3, ext=[AuthorCompanyExt(id=1321425579321184569, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, companyId=1321425579304407352, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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3中国生物技术股份有限公司，北京 100024)])]), Author(id=1321425580805968207, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425580898242897, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, authorId=1321425580805968207, language=EN, stringName=Shu-yan ZUO, firstName=Shu-yan, middleName=null, lastName=ZUO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3中国生物技术股份有限公司，北京 100024, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425579304407352, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, xref=3, ext=[AuthorCompanyExt(id=1321425579321184569, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, companyId=1321425579304407352, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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3中国生物技术股份有限公司，北京 100024)])]), Author(id=1321425581179261268, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425581271535958, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, authorId=1321425581179261268, language=EN, stringName=Yuan YUAN, firstName=Yuan, middleName=null, lastName=YUAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
4, address=
4Program for Appropriate Technology in Health, Shanghai 200120, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425582919897432, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, authorId=1321425581179261268, language=CN, stringName=袁瑗, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1Department of Global Health, School of Public Health, Peking University, Beijing 100191, China
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1, 2, *, address=
1北京大学公共卫生学院全球卫生学系，北京 100191
2北京大学全球健康发展研究院，北京 100191, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1321425579115663666, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, xref=1, ext=[AuthorCompanyExt(id=1321425579124052275, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425576905265454, companyId=1321425579115663666, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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