Article(id=1321425857546142611, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.15.001, 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=1753804800000, acceptedDateStr=2025-07-30, onlineDate=1792982075343, onlineDateStr=2026-10-26, pubDate=1786723200000, pubDateStr=2026-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982075343, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982075343, creator=13701087609, updateTime=1792982075343, updator=13701087609, issue=Issue{id=1321425812331549069, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='15', pageStart='1569', pageEnd='1680', issueExtLink='null', onlineDate='null', pubDate='1786723200000', pubDateStr='2026-08-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982064564, creator='13701087609', updateTime=1792982904202, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429334083097400, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429334087291705, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425812331549069, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1569, endPage=1576, ext={EN=ArticleExt(id=1321425857890075540, articleId=1321425857546142611, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Quantitative analysis of policy texts related to subject responsibility for drug quality and safety in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To reveal the evolution trend of the objectives of policies related to the subject responsibility for drug quality and safety in China and the possible deficiencies through a quantitative analysis of policy texts, thereby providing a basis for optimizing the drug regulatory system and promoting the implementation of the subject responsibility.
Methods: This study mainly employed text mining and co-word analysis method, through utilizing ROSTCM6 software to perform word segmentation, word frequency statistics, and semantic network analysis on 37 policy documents issued at the national level between 2012 and 2025, to explore the distribution patterns of high-frequency thematic words and the characteristics of policy evolution.
Results: The study found that the policies present characteristics of "phased evolution”: the subject words gradually transform from "quality" and "enterprise" in the initial stage to "holder" and "management", the semantic network structure has changed from loose to tight, and the focus of supervision is shifting from the "responsible subject" to the dual-track mechanism of "centralization of the responsible subject and refinement of the subject responsibility”.
Conclusion: China has gradually established a responsibility system covering the entire life cycle of drugs, but it still needs to further refine the definition of responsibilities and strengthen quality management.
, authors=Jing-chun SUN
1, Tian-yu LIU
1, Yue-jiao CHEN
1, Shu-xiang LI
1, Shu-zhen CHU
1, 2, *, authorsList=Jing-chun SUN, Tian-yu LIU, Yue-jiao CHEN, Shu-xiang LI, Shu-zhen CHU, authorCompany=null, correspAuthors=Shu-zhen CHU, 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=1321425858296923029, articleId=1321425857546142611, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=政策工具视角下我国落实药品质量安全主体责任相关政策演变分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=
目的： 对我国药品质量安全主体责任相关的政策文本量化分析，揭示政策目标的演变趋势及其可能存在的不足，从而为优化药品安全监管体系、推动主体责任落实提供依据。
方法： 主要采用文本挖掘与共词分析法，对2012—2025年国家层面发布的37项政策文本借助ROSTCM6文本分析工具进行分词、词频统计及语义网络分析，以探究高频主题词的分布规律及政策演变特征。
结果： 研究发现，相关政策呈现“阶段式演进”的特点，主题词从初期的“质量”“企业”逐渐转向“持有人”“管理”，语义网络结构由松散趋向紧密，监管重心正逐渐从“责任主体”向“责任主体中心化+主体责任精细化”的双轨机制转移。
结论： 我国已逐步构建起覆盖药品全生命周期的责任体系，但仍须进一步细化责任界定，强化质量管理。
, authors=孙净淳
1, 刘天宇
1, 陈月娇
1, 李树祥
1, 褚淑贞
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孙净淳，女，硕士研究生，研究方向：医药产业经济与政策。E-mail: sunjingchun09@163.com。
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