Article(id=1322127434158288972, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, 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=1637510400000, acceptedDateStr=2021-11-22, onlineDate=1793149344243, onlineDateStr=2026-10-28, pubDate=1640793600000, pubDateStr=2021-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149344243, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149344243, creator=13701087609, updateTime=1793149344243, updator=13701087609, issue=Issue{id=1322127420036071763, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='24', pageStart='2225', pageEnd='2327', issueExtLink='null', onlineDate='null', pubDate='1640793600000', pubDateStr='2021-12-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149340876, creator='13701087609', updateTime=1793149575427, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128403881374295, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128403881374296, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2242, endPage=2248, ext={EN=ArticleExt(id=1322127434388975693, articleId=1322127434158288972, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Study on ability evaluation model for drug review authority, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

According to the spirit of the “implementation opinion on comprehensive strengthening of the drug regulatory capacity construction” issued by the General Office of the State Council, this article aimed to provide reference for the evaluation benchmark and future direction for the improvement of drug evaluation ability under the strategy of pharmaceutical power. According to the dual organization theory, lessons were drawn from WHO and EMA competence assessment for regulatory authorities, and the drug evaluation ability model was constructed by using two rounds of expert investigation method of Delphi. The drug evaluation ability model was composed of input, process control and output modules, which contained 16 primary indicators of core competency assessment and 58 secondary indicators altogether. It will provide a basis for the assessment of the ability of drug review authority in China in the new period, to find the gap between vision and reality, to improve the ability of drug review from the long-term goal, and to promote the capability development of drug review authority.

, authors=Feng LI, authorsList=Feng LI, authorCompany=null, correspAuthors=null, 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=1322127434653216846, articleId=1322127434158288972, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=药品审评能力模型构建研究, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

根据国务院办公厅《关于全面加强药品监管能力建设的实施意见》（国办发〔2021〕16号）文件精神，探索定量化的药品审评能力评估模型，为制药强国战略下药品审评能力的提升提供评估基准和未来方向的参考。根据二元组织理论，借鉴WHO和EMA监管机构能力评估方法，采用Delphi两轮专家调研法，构建药品审评能力模型。药品审评能力模型中包括输入类、过程控制类和输出类能力模块，共包含16个一级核心能力评估指标，58个二级指标。该审评能力模型将为新时期我国药品审评机构能力评估、寻找审评能力差距、从长期目标出发提升药品审评能力、促进药品审评机构改革和发展提供借鉴。

, authors=李峰, authorsList=李峰, authorCompany=null, correspAuthors=null, authorNote=, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=VTjYuwNJfSiB7p9l4JxbdA==, magXml=FbFAJNc4rund+FYoRDVF1w==, pdfUrl=null, pdf=NYbFUeiDKIajoiMy3/fl9g==, pdfFileSize=2914983, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=QM/qVOtBSOVslOrPNsjCPQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322127435026509907, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127434158288972, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=lif@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322127435143950421, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127434158288972, authorId=1322127435026509907, language=EN, stringName=Feng LI, firstName=Feng, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medicinal Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322127435253002326, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322127434158288972, authorId=1322127435026509907, language=CN, stringName=李峰, 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":"

李峰，男，博士，正高级经济师，主要从事药品监管科学和产业政策研究。联系电话：（010）85243391，E-mail：lif@cde.org.cn。

"}, bioImg=null, bioContent=

李峰，男，博士，正高级经济师，主要从事药品监管科学和产业政策研究。联系电话：（010）85243391，E-mail：lif@cde.org.cn。

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