Article(id=1321426291270730463, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.16.002, 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=1754323200000, acceptedDateStr=2025-08-05, onlineDate=1792982178752, onlineDateStr=2026-10-26, pubDate=1788019200000, pubDateStr=2026-08-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982178752, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982178752, creator=13701087609, updateTime=1792982178752, updator=13701087609, issue=Issue{id=1321426285826519296, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='16', pageStart='1681', pageEnd='1792', issueExtLink='null', onlineDate='null', pubDate='1788019200000', pubDateStr='2026-08-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982177454, creator='13701087609', updateTime=1792982881356, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429238297776921, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429238297776922, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321426285826519296, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1689, endPage=1693, ext={EN=ArticleExt(id=1321426291505611488, articleId=1321426291270730463, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A comparative analysis of regulatory policies of ICH Q12 for post-approval chemical, manufacture and control changes of chemical drugs in China and Europe, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To put forward some suggestions on post-approval change management of drugs based on ICH Q12 for our country.
Methods: The EU and China regulatory frameworks and classification requirements of post-approval CMC changes of chemical drugs under ICH Q12 were studied, and our deficiencies on management of post-approval drug changes were analyzed.
Results: The EU has issued the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management-Scientific Guideline, which establishes a globally recognized framework. This guideline demonstrates mature lifecycle management concepts, comprehensive management tools, clear change procedures, and efficient review communications. It enables enterprises to better understand critical elements of products and manufacturing processes through ICH Q12 tools, facilitates more efficient implementation of post-approval CMC changes, reduces corporate change costs, and conserves regulatory review resources.
Conclusion: China can dram on the mature experience of EU regulatory authorities to optimize its post-approval CMC change management system in accordance with ICH Q12. These measures would enhance the efficiency and scientific rigorousness of pharmaceutical post-approval CMC change management in China while alleviating burdens on marketing authorization holders (MAHs) and regulatory authorities.
, authors=Hui-lan ZHANG
1, Zhe HUANG
1, 2, *, authorsList=Hui-lan ZHANG, Zhe HUANG, authorCompany=null, correspAuthors=Zhe 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=1321426291841155809, articleId=1321426291270730463, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=ICH Q12化学药品上市后变更的中欧监管政策比较分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=
目的： 依据ICH《Q12：药品生命周期管理的技术和监管考虑》为我国药品上市后变更管理提供建议。
方法： 研究我国和欧盟监管机构对化学药品上市后ICH Q12变更管理的相关法规和分类要求，分析比较我国和欧盟监管机构的管理差异以及存在问题。
结果： 欧盟提供了一个可供全球认可的框架，即成熟的生命周期管理理念、完善的管理工具、清晰的变更程序、顺畅的审核沟通，帮助企业通过ICH Q12工具更好地理解产品和生产工艺的关键要素，支持企业更良好、更高效地实施上市后化学、生产和控制（chemical, manufacture and control, CMC）变更，降低企业变更成本，节约监管机构的审评资源。
结论： 我国可以借鉴欧盟监管机构的成熟经验，依据ICH Q12优化我国药品批准后变更管理体系，这将有助于提升我国药品批准后CMC变更管理的效率和科学性，同时减轻药品上市许可持有人和监管部门的负担。
, authors=张慧兰
1, 黄哲
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