Article(id=1236344972232937856, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, articleNumber=null, orderNo=null, doi=null, 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=1664121600000, acceptedDateStr=2022-09-26, onlineDate=1772697211559, onlineDateStr=2026-03-05, pubDate=1678809600000, pubDateStr=2023-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697211559, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697211559, creator=13701087609, updateTime=1772697211559, updator=13701087609, issue=Issue{id=1236344966058931117, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697210087, creator=13701087609, updateTime=1772697640190, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346770087793082, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346770087793083, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236344966058931117, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=476, endPage=480, ext={EN=ArticleExt(id=1236344972497179016, articleId=1236344972232937856, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Introduction to selection and management of reference listed drug for chemical generic drugs in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Reference listed drug, as the benchmark of generic drugs, is the reference drug for the consistency evaluation of quality and efficacy of a generic drug. As the starting point of developing a generic drug, reference listed drug selection is of great significance in the whole process of research and development. This paper comprehensively reviews the policy requirements of reference listed drug selection, and compares the regulation patterns on reference listed drug in China and the United States. Moreover, the common issues on those refused reference listed drug applications are summarized, and the reasons on reference listed drug alteration are analyzed. Consequently, it is expected that the principles and approaches of reference listed drug selection would be further clarified for the reference of the applicants.

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参比制剂作为仿制药的标杆，是仿制药质量和疗效一致性评价研究的对照药品，其遴选工作是开展药品仿制的起点，对仿制药研究具有重要意义。本文将全面梳理我国参比制剂遴选工作的政策要求，对比中美两国监管机构对参比制剂的管理方式，并对我国参比制剂目录未通过品种与已发布化学仿制药参比制剂调整情况进行分析，以期进一步明晰我国仿制药参比制剂的遴选原则，理清参比制剂遴选思路，为申请人选择参比制剂提供参考。

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张卓成，男，硕士研究生，研究方向：药学，工业药剂学，仿制药质量和疗效一致性评价。E-mail: zzc_cpu@163.com。

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张卓成，男，硕士研究生，研究方向：药学，工业药剂学，仿制药质量和疗效一致性评价。E-mail: zzc_cpu@163.com。

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