Article(id=1322180337963225731, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, 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=1617033600000, acceptedDateStr=2021-03-30, onlineDate=1793161957493, onlineDateStr=2026-10-28, pubDate=1628956800000, pubDateStr=2021-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161957493, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161957493, creator=13701087609, updateTime=1793161957493, updator=13701087609, issue=Issue{id=1322180330556076791, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='15', pageStart='1345', pageEnd='1440', issueExtLink='null', onlineDate='null', pubDate='1628956800000', pubDateStr='2021-08-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161955726, creator='13701087609', updateTime=1793162082189, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322180861076816464, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322180861076816465, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1361, endPage=1366, ext={EN=ArticleExt(id=1322180338189718148, articleId=1322180337963225731, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Standardization of application materials and evidence in the negotiation access system of innovative medicines and medical insurance, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article first sorts out the relevant requirements for application materials and evidence in the practice of China's medical insurance negotiation, and analyzes the problems that exist in China. On this basis, the supporting materials of new drug medical insurance access negotiations in New Zealand, Australia, Canada and other countries were studied in detail. Then we compare China with the above-mentioned countries to analyze the gap between China and these countries in the standardization of application materials and evidence, providing enlightenment and policy recommendations from the experience of New Zealand and other developed countries on China's medical insurance access negotiations, including the preparation of the Chinese version of “Official Guide on Innovative Medicines and Medical Insurance Access”, providing detailed requirements and related templates; optimization of the material framework to form a modular and clear-level supporting material system; strengthening material quality requirements, data source standards and introduction of a self-inspection mechanism.

, authors=Xu-feng MA, Jian-zhou YAN, Rong SHAO, authorsList=Xu-feng MA, Jian-zhou YAN, Rong SHAO, authorCompany=null, correspAuthors=Rong SHAO, 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=1322180338500096645, articleId=1322180337963225731, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=创新药品医保谈判准入制度中申报材料和证据的标准化研究, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

本文梳理了我国医保谈判实践中对申报材料和证据的相关要求，分析了其中存在的问题，在此基础上对新西兰、澳大利亚、加拿大等国家的创新药品医保准入谈判中的支撑材料进行了详细研究。将我国与上述国家进行对比，分析两者在申报材料和证据标准化方面的差距，探究新西兰等发达国家经验对我国医保准入谈判的启示和政策建议，包括编写中国版《创新药品医保准入申请官方指南》，提供详尽的要求说明和相关模板；优化材料框架，形成模块、层次清晰的支撑材料体系；加强材料质量要求，规范数据来源并引入自查机制。

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马旭锋，男，硕士研究生，研究方向：医药政策与法规。E-mail：nbdjzyr@163.com。

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马旭锋，男，硕士研究生，研究方向：医药政策与法规。E-mail：nbdjzyr@163.com。

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pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=立波. 简评我国医保药品准入谈判之报送材料清单[EB/OL]. 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