Article(id=1322901647847993587, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, 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=1602691200000, acceptedDateStr=2020-10-15, onlineDate=1793333931155, onlineDateStr=2026-10-30, pubDate=1626278400000, pubDateStr=2021-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793333931155, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793333931155, creator=13701087609, updateTime=1793333931155, updator=13701087609, issue=Issue{id=1322901641049015115, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='13', pageStart='1153', pageEnd='1248', issueExtLink='null', onlineDate='null', pubDate='1626278400000', pubDateStr='2021-07-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793333929460, creator='13701087609', updateTime=1793333989426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322901892623376986, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322901892627571291, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322901641049015115, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1164, endPage=1167, ext={EN=ArticleExt(id=1322901649957728500, articleId=1322901647847993587, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis and discussion of generic drug consistency evaluation in NMPA and relevant drug policies in FDA and PMDA, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Generic drug has made a large contribution to our medical security system; however, the pharmaceutical industry starts late in China and there still exists a wide gap between generic drugs and original drugs. Given this situation, the generic drug consistency evaluation is extremely meaningful to ensure the efficacy and safety of generic drugs, and it is impressive for improving the integral level of pharmaceutical industry. This article discusses the relevant policies of the generic drug consistency evaluation in China, such as ensuring the consistency between generic drugs and original drugs, establishment of the strict review and supervision system, etc. At the same time, this article also outlines the relevant drug policies and their development process in US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA). We expect that the comparison and analysis would be benefit to the generic drug consistency evaluation in our country.

, authors=Dong LI, Hong-jin DU, Yu ZHOU, Dong LIU, Yi-lin LIU, Li-li HA, Fang LI, Jin-bo YANG, authorsList=Dong LI, Hong-jin DU, Yu ZHOU, Dong LIU, Yi-lin LIU, Li-li HA, Fang LI, Jin-bo YANG, authorCompany=null, correspAuthors=Jin-bo 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=1322901652394619125, articleId=1322901647847993587, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中国仿制药一致性评价政策与美国、日本相关政策的分析与讨论, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

我国是仿制药大国，仿制药品为我国基本的医疗保障做出了巨大的贡献，但我国医药行业起步较晚，仿制药品与原研药品在质量和疗效方面存在一定差距。因此，开展仿制药一致性评价工作，对保障仿制药品有效性和安全性、提升我国制药行业整体水平等具有重要的意义。本文讨论了我国确保仿制药品与原研药品一致、建立上市前严格审评和上市后严密监管体系等仿制药一致性评价相关处理方法和政策，同时概述了美国和日本相关药品政策和发展历程，以期对我国仿制药一致性评价工作继续推进与完善有所借鉴。

, authors=李栋, 杜宏金, 周誉, 刘冬, 刘意林, 哈莉莉, 李芳, 杨进波, authorsList=李栋, 杜宏金, 周誉, 刘冬, 刘意林, 哈莉莉, 李芳, 杨进波, authorCompany=null, correspAuthors=杨进波, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=lTE7Wb8FZlcXuRWX/EhRWQ==, magXml=Y/GYuuqAQMmttaaryuWqUg==, pdfUrl=null, pdf=+1qCjuC4LZTGKt1CfQSzsA==, pdfFileSize=861607, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=WReWWmUqCdxCcc8jp/2NdA==, mapNumber=null, fund=null)}, authors=[Author(id=1322901659566878970, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322901647847993587, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=lidong@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322901660099555580, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322901647847993587, authorId=1322901659566878970, language=EN, stringName=Dong LI, firstName=Dong, middleName=null, lastName=LI, 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=1322901660334436605, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322901647847993587, authorId=1322901659566878970, language=CN, stringName=李栋, 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":"

李栋，男，主管药师，主要从事临床药理学技术审评工作。联系电话：（010）85243548，E-mail：lidong@cde.org.cn。

"}, bioImg=null, bioContent=

李栋，男，主管药师，主要从事临床药理学技术审评工作。联系电话：（010）85243548，E-mail：lidong@cde.org.cn。

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