Article(id=1322125558264214509, 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=1635350400000, acceptedDateStr=2021-10-28, onlineDate=1793148896994, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148896994, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148896994, creator=13701087609, updateTime=1793148896994, 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=2053, endPage=2058, ext={EN=ArticleExt(id=1322125558436180974, articleId=1322125558264214509, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Consideration on the implementation of ICH M4Q, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The experience in the implementation of ICH M4Q in China was summarized, regarding the chemistry, manufacture & control (CMC) dossiers of chemical and biological drugs. Because ICH has developed many important quality and multidisciplinary guidelines after the implementation of ICH M4Q (R1) version, this article discussed the specific requirements and major problems of CTD format in combination with the current technical guidelines.

, authors=Juan LIU, Li-ting ZHOU, Hong YU, Wu HE, Ning ZHANG, authorsList=Juan LIU, Li-ting ZHOU, Hong YU, Wu HE, Ning ZHANG, authorCompany=null, correspAuthors=Ning ZHANG, 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=1322125558700422127, articleId=1322125558264214509, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=ICH M4Q指导原则实施的思考, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

本文梳理总结了我国化学药品和生物制品药学申报资料格式实施ICH M4Q指导原则的经验，同时结合M4Q（R1）版本实施后ICH发布的多项质量和综合性技术指导原则，就药学申报资料遵循通用技术文档（CTD）格式的具体技术要求和主要问题进行了探讨。

, authors=刘涓, 周莉婷, 于红, 何伍, 张宁, authorsList=刘涓, 周莉婷, 于红, 何伍, 张宁, authorCompany=null, correspAuthors=张宁, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=uekqPjbyEXt/mgmX+iYpYA==, magXml=LJkUXkFXZ3XHeVrHfR7MYQ==, pdfUrl=null, pdf=XHayS1yuVk80+8v18AtKJw==, pdfFileSize=996201, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=TddikSlGMaOmvIdn7oEvnA==, mapNumber=null, fund=null)}, authors=[Author(id=1322125559035966452, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125558264214509, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=liuj@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322125559111463926, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125558264214509, authorId=1322125559035966452, language=EN, stringName=Juan LIU, firstName=Juan, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322125559191155703, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125558264214509, authorId=1322125559035966452, language=CN, stringName=刘涓, 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":"

刘涓，女，主管药师，主要从事化学药品技术审评工作。联系电话：（010）85242866，E-mail：liuj@cde.org.cn。

"}, bioImg=null, bioContent=

刘涓，女，主管药师，主要从事化学药品技术审评工作。联系电话：（010）85242866，E-mail：liuj@cde.org.cn。

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