Article(id=1236366103513985197, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, 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=1668355200000, acceptedDateStr=2022-11-14, onlineDate=1772702249649, onlineDateStr=2026-03-05, pubDate=1675008000000, pubDateStr=2023-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702249649, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702249649, creator=13701087609, updateTime=1772702249649, updator=13701087609, issue=Issue{id=1236366095871955240, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='2', pageStart='113', pageEnd='216', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702247826, creator=13701087609, updateTime=1772702896580, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236368817010561584, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236368817010561585, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=189, endPage=197, ext={EN=ArticleExt(id=1236366103719506099, articleId=1236366103513985197, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A brief introduction to the policy and criteria for conditional approval of innovative anti-tumor drugs in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In order to encourage clinical value-oriented drug innovation, the current "Drug Registration Regulation" proposes four expedited regulatory approval procedures. For innovative drugs with early clinical trial data that can likely predict the efficacy and clinical benefit of the drugs, the marketing authorization might be granted before the completion of the confirmatory clinical trial through the conditional approval procedure, with all data comprehensively reviewed. By implementing the procedure, patients with serious diseases or conditions can expect more opportunities to prolong their lives or improve their quality of life. Since conditional approval procedures can shorten the time for pre-market clinical research and development, its supporting policies and criteria have attracted much attention. This paper takes the innovative anti-tumor drugs as the starting point, systematically sorts out the policy requirements of conditional approval in China and the criteria that have been formed in the review process, and tries to analyze the problems encountered in the implementation of conditional approval and put forward solutions.

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为了鼓励以临床价值为导向的药物创新，现行《药品注册管理办法》明确提出了4种加快上市注册的程序。对于早期临床试验数据可证实药物疗效并能预测其临床价值的创新药，经评价后可以通过附条件批准工作程序，在完成确证性临床研究之前上市，让有严重危及生命且尚无治疗手段的患者获得更多延长其生命或改善其生活质量的治疗机会。附条件批准工作程序可以缩短药品上市前的临床研发时间，因此其配套政策和审评标准备受关注。本文以肿瘤创新药为切入点，对我国附条件批准的政策要求和审评过程中已经形成的标准进行系统的梳理，并尝试对附条件批准实施过程中遇到的问题进行分析并提出建议，供业界参考。

, correspAuthors=null, authorNote=null, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=WUesenHEmhk+csWYvb9iAA==, magXml=R85uOxwPvWwtB8PPbb9FJA==, pdfUrl=null, pdf=E4mx/nTHaCH4Bue1rjE0vQ==, pdfFileSize=12974352, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=au4V2lhwK/OIArKGOOFGgw==, mapNumber=null, authorCompany=null, fund=null, authors=, authorsList=齐玥丽, 邹丽敏, 蒋永麟, 唐凌, 杜瑜, 赵伯媛, 孙艳喆, 相美亦, 杨志敏)}, authors=[Author(id=1236366104227016895, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236366103513985197, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=qiyl@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236366104306708673, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236366103513985197, authorId=1236366104227016895, language=EN, stringName=Yue-li QI, firstName=Yue-li, middleName=null, lastName=QI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medicine Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236366104382206147, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236366103513985197, authorId=1236366104227016895, language=CN, stringName=齐玥丽, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio={"content":"

齐玥丽，硕士，助理研究员，主要从事药品临床审评工作。E-mail: qiyl@cde.org.cn。

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齐玥丽，硕士，助理研究员，主要从事药品临床审评工作。E-mail: qiyl@cde.org.cn。

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邹丽敏，博士，副研究员，主要从事药品临床审评工作。E-mail: zoulm@cde.org.cn。

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邹丽敏，博士，副研究员，主要从事药品临床审评工作。E-mail: zoulm@cde.org.cn。

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