Article(id=1322906843009392726, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, 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=1612195200000, acceptedDateStr=2021-02-02, onlineDate=1793335169793, onlineDateStr=2026-10-30, pubDate=1635523200000, pubDateStr=2021-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335169793, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335169793, creator=13701087609, updateTime=1793335169793, updator=13701087609, issue=Issue{id=1322906824709648449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='20', pageStart='1825', pageEnd='1920', issueExtLink='null', onlineDate='null', pubDate='1635523200000', pubDateStr='2021-10-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793335165428, creator='13701087609', updateTime=1793337419278, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916278284976934, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916278284976935, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1825, endPage=1829, ext={EN=ArticleExt(id=1322906843172970583, articleId=1322906843009392726, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Positive effect of review and approval system reform on clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Since the publication of Opinions of the State Council on the Reform of Drug and Medical Device Review and Approval System in 2015, the original CFDA and the current NMPA carried out a series of reform on the review and approval system to make the clinical trials in China to meet the international levels and reduce the large number of reviews and approvals waiting in line, and China successfully joined the ICH in June 2017. The reform exerted some positive effects on clinical trial conducting in China, which were analyzed and reviewed in this article.

, authors=Na NI¹, Ran-ran CUI², Yan ZHENG², hong-zhi DENG², Bin ZHOU¹, authorsList=Na NI, Ran-ran CUI, Yan ZHENG, hong-zhi DENG, Bin ZHOU, authorCompany=null, correspAuthors=Bin ZHOU, 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=1322906843428823128, articleId=1322906843009392726, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=审评审批管理制度改革对临床试验开展的促进作用, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

2015年以来，随着《国务院关于改革药品医疗器械审评审批制度的意见》的出台，原国家食品药品监督管理总局及国家药品监督管理局针对国内临床试验水平急需与国际接轨、药品临床试验审评审批积压等问题，开展了一系列相关管理制度的改革，并促成我国于2017年6月加入国际人用药品注册技术协调会（ICH），对国内临床试验的开展具有许多积极的意义。本文重点根据所颁布的管理制度对临床试验产生的促进作用进行分析评述。

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倪娜，女，硕士，主要从事临床研究工作。联系电话：（021）54234291，E-mail：ni.n@incrom.com.cn。

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倪娜，女，硕士，主要从事临床研究工作。联系电话：（021）54234291，E-mail：ni.n@incrom.com.cn。

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