Article(id=1321425628952379434, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425597998420385, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.08.008, 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=1755532800000, acceptedDateStr=2025-08-19, onlineDate=1792982020842, onlineDateStr=2026-10-26, pubDate=1777478400000, pubDateStr=2026-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982020842, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982020842, creator=13701087609, updateTime=1792982020842, 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=847, endPage=852, ext={EN=ArticleExt(id=1321425629124345899, articleId=1321425628952379434, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Practical exploration and optimization pathways of China's resident vaccine inspector system, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

As critical biological products related to public health security, vaccines require specialized quality regulation with strategic significance. Against the backdrop of the implementation of the Vaccine Administration Law of the People's Republic of China, this study focuses on China's resident vaccine inspector system. Through in-depth interviews with 19 stakeholders from regulatory agencies and vaccine enterprises, combined with policy text analysis, the research systematically examines the operational mechanisms and implementation outcomes of the system. It was revealed that the resident inspector system, underpinned by a preventive regulatory model of "on-site facility supervision, risk early warning, and rectification closed-loop", demonstrates significant efficacy in controlling quality risks at the source and enhancing corporate compliance. However, there exist structural challenges, including discontinuities in talent echelons, fragmented training systems, insufficient incentive mechanisms, lagging digital capabilities, and immature coordination mechanisms between dispatched inspections and daily supervision. To address these issues, the study proposes a five-in-one optimization framework integrating "professional talent selection, systematic training, quantitative evaluation, technological empowerment, and mechanism linkage”. Specific recommendations include establishing cross-regional talent-sharing mechanisms to alleviate workforce shortages, adopting a combined training model of "theoretical learning, practical drills, and simulated inspections" to enhance competency, develop a KPI assessment system based on risk detection metrics and corporate satisfaction, strengthen digital system operation training and information and intelligent terminal equipment, enhance the coordinated development of dispatched inspection and daily supervision. The research provides theoretical support for improving the vaccine lifecycle regulatory system, offers practical insights for enhancing regulatory precision and mitigating systemic quality risks.

, authors=Jin-zi WANG¹, Han TANG¹, Xian-xing XU¹, Ti-deng ZHANG¹, Zhe HUANG^{2, 3, *}, Jia-hui YE^{4, *}, authorsList=Jin-zi WANG, Han TANG, Xian-xing XU, Ti-deng ZHANG, Zhe HUANG, Jia-hui YE, authorCompany=null, correspAuthors=Zhe HUANG, Jia-hui YE, 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=1321425629363421228, articleId=1321425628952379434, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中国疫苗派驻检查员制度的实践探索与优化路径, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

疫苗作为关系公共卫生安全的重要生物制品，其质量监管具有特殊战略意义。本研究以《中华人民共和国疫苗管理法》实施为背景，聚焦中国疫苗派驻检查员制度的实践探索，通过深度访谈19名监管部门及企业相关人员，结合政策文本分析，系统考察该制度的运行机制与实施成效。研究发现，派驻检查员制度通过“驻厂监管-风险预警-整改闭环”的预防性监管模式，在源头防控质量风险、提升企业合规性方面成效显著，但存在人才梯队断层、培训体系碎片化、激励机制缺失、数字化监管能力滞后、派驻检查和日常监管的协同机制尚不成熟等结构性矛盾。针对现存问题，提出构建“专业人才选拔-系统化培训-量化考核-技术赋能-机制联动”五位一体的优化路径：通过跨区域人才共享机制破解专业力量不足困境，以“理论+实训+模拟检查”组合式培训提升检查能力，建立基于风险发现数与企业满意度的KPI考核体系，强化数字系统操作培训与信息化和智能化终端配备，并强化派驻检查与日常监管的协同发展。本研究为完善疫苗全生命周期监管体系提供理论支撑，对提升监管精准度、防范系统性质量风险具有实践参考价值。

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王金子，女，讲师，研究方向：药品上市后监管。E-mail: wjz@nmpaied.org.cn。

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王金子，女，讲师，研究方向：药品上市后监管。E-mail: wjz@nmpaied.org.cn。

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