Article(id=1321425571427500688, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.004, 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=1764604800000, acceptedDateStr=2025-12-02, onlineDate=1792982007127, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982007127, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982007127, creator=13701087609, updateTime=1792982007127, 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=695, endPage=700, ext={EN=ArticleExt(id=1321425571641410193, articleId=1321425571427500688, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The complete response letter in FDA's review decision feedback mechanism and its implications for China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

By sorting out the development history, specific content, institutional advantages, and challenges of the complete response letter system in the U.S. evaluation decision feedback mechanism, as well as the current situation of drug evaluation feedback mechanism in China, suggestions for China's evaluation decision feedback mechanism were put forward. The U.S. complete response letter system has certain institutional advantages in improving the transparency of evaluation and guiding applicants' subsequent research and development, thereby contributing to the advancement of the U.S. pharmaceutical industry. China needs to carry out appropriate transformation in combination with its own regulatory practices and external environment. For innovative drugs and other drugs with clinical application prospects, on the premise of informing applicants of "why it is not feasible", further guidance should be provided on "what to do next”; internal evaluation procedures should be optimized to improve the continuity of evaluation; common reasons for rejection of approval should be summarized regularly to provide experience for applicants, avoiding repeated detours; public laws and regulations should be gradually improved to achieve a balance between "disclosure" and "protection”. This article provides references for improving the feedback mechanism of drug evaluation and decision-making in China.

, authors=Jian LU, Ming-quan SHA, Mei-yi DONG, Yu BAI^*, authorsList=Jian LU, Ming-quan SHA, Mei-yi DONG, Yu BAI, authorCompany=null, correspAuthors=Yu BAI, 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=1321425571926622866, articleId=1321425571427500688, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国FDA药品审评决策反馈机制中完整回复函制度对我国药品监管的启示, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文通过梳理美国审评决策反馈机制中完整回复函（complete response letter, CRL）制度的发展历程、具体内容、制度优势及面临的挑战，以及我国药品审评反馈机制的现状，对我国审评决策反馈机制提出建议。美国CRL制度在提高审评透明度、指导申请人后续研发等方面存在一定的制度优势，有力地促进了美国医药产业的发展。我国监管部门需结合监管实践和外部环境进行适当转化，对创新药及其他具有临床应用前景药品，在告知申请人“为什么不行”的前提下，再进一步指导申请人“后续怎么办”；优化内部审评程序，提高审评连续性；定期总结共性拒绝批准原因，为申请人提供经验借鉴，避免重复走弯路；逐步完善公开法律法规，实现“公开”与“保护”之间的平衡，以期为完善我国药品审评决策反馈机制提供参考。

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陆建，女，硕士研究生，研究方向：药品监管。E-mail: luj@cde.org.cn。

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陆建，女，硕士研究生，研究方向：药品监管。E-mail: luj@cde.org.cn。

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