Article(id=1322125562517242276, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, 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=1630252800000, acceptedDateStr=2021-08-30, onlineDate=1793148898008, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148898008, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148898008, creator=13701087609, updateTime=1793148898008, updator=13701087609, issue=Issue{id=1322125552731927464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='22', pageStart='2017', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='1638201600000', pubDateStr='2021-11-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793148895675, creator='13701087609', updateTime=1793149501548, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128094022971944, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128094022971945, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322125552731927464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2034, endPage=2041, ext={EN=ArticleExt(id=1322125562731151781, articleId=1322125562517242276, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on the adaptive licensing pathway for new drug registration in EU and its enlightenment to China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Adaptive licensing pathway is one of the most characteristic rapid marketing authorization routes of new drugs in EU. This path is based on the conditional marketing authorization path, but is different from the traditional marketing approval path. Its main feature is to use prospective iterative evidences to bring drugs with potential clinical value to the market as soon as possible. This paper studied the application standards, entry procedures, approval model, operation mechanism and implementation experience of the adaptive licensing pathway, thus to provide valuable references for the exploration and construction of adaptive licensing pathway of new drug registration in China.

, authors=Di WU, Li YANG, Yan-yi WEI, Yu-wen CHEN, Zu-guang WANG, Ze-ying YANG, authorsList=Di WU, Li YANG, Yan-yi WEI, Yu-wen CHEN, Zu-guang WANG, Ze-ying YANG, authorCompany=null, correspAuthors=Li YANG, 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=1322125563410629030, articleId=1322125562517242276, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=欧盟新药注册适应性批准路径研究及启示, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

新药注册适应性批准是欧盟最具特色的新药快速上市路径之一。该路径建立在有条件批准路径之上，但是有别于传统的批准路径，主要特点在于运用前瞻性迭代证据将具有潜在临床价值的药物尽早推向市场。本文对欧盟新药注册适应性批准路径的适用范围、进入程序、批准模型、运行机制、实施经验等进行深入研究，为我国新药注册适应性批准路径的探索和构建提供借鉴。

, authors=吴迪, 杨莉, 韦彦伊, 陈玉文, 王祖光, 杨泽瀛, authorsList=吴迪, 杨莉, 韦彦伊, 陈玉文, 王祖光, 杨泽瀛, authorCompany=null, correspAuthors=杨莉, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=H0ocTM5BdzbNKw2oou9l+A==, magXml=KNCqMO2MAdRCWxV+xBqOqA==, pdfUrl=null, pdf=2evYr6eP3gs2DDg8hVpCHQ==, pdfFileSize=1613251, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=y+itRd34pfm2upHkG+/iBg==, mapNumber=null, fund=null)}, authors=[Author(id=1322125563750367659, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125562517242276, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=diwu9834@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322125563855225261, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125562517242276, authorId=1322125563750367659, language=EN, stringName=Di WU, firstName=Di, middleName=null, lastName=WU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322125563939111342, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125562517242276, authorId=1322125563750367659, language=CN, stringName=吴迪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=沈阳药科大学工商管理学院，沈阳　110016, bio={"content":"

吴迪，女，硕士研究生，研究方向：药品法规与政策、监管科学。E-mail：diwu9834@163.com。

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吴迪，女，硕士研究生，研究方向：药品法规与政策、监管科学。E-mail：diwu9834@163.com。

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tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125562517242276, language=CN, orderNo=4, keyword=适应性批准)], refs=[Reference(id=1322125566149509587, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125562517242276, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=New Drug Development Paradigms. 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