Article(id=1322125553876979944, 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=1628438400000, acceptedDateStr=2021-08-09, onlineDate=1793148895948, onlineDateStr=2026-10-28, pubDate=1638201600000, pubDateStr=2021-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793148895948, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793148895948, creator=13701087609, updateTime=1793148895948, 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=2017, endPage=2023, ext={EN=ArticleExt(id=1322125554057335017, articleId=1322125553876979944, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Preliminary thinking on the establishment of China's future pharmacovigilance system, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

With the increasing number of new drugs on the market, the risk of drug safety also increases. The establishment of pharmacovigilance system is proposed in the Drug Administration Law, which is of great significance to the future research and development of new drugs and drug supervision. Pharmacovigilance system includes management and technical activities. The implementation of China's pharmacovigilance system meets the requirements of new regulations and systems. This article discusses the concept and scope of the implementation of China's future pharmacovigilance system, the key points of the transformation from the adverse reaction monitoring and reporting system to the pharmacovigilance system, and the obligations and responsibilities of all parties in the pharmacovigilance system.

, authors=Ya-juan ZHANG, Hui CHEN, Yue YANG, authorsList=Ya-juan ZHANG, Hui CHEN, Yue YANG, authorCompany=null, correspAuthors=Yue 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=1322125554715840746, articleId=1322125553876979944, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=面向未来的中国药物警戒制度实施的思考, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

随着我国新药上市的数量和速度不断提高，上市后的药品安全风险管理更加重要。2019年新修订的《中华人民共和国药品管理法》提出建立药物警戒制度，对未来新药研发及药品监管有重要意义。药物警戒体系包括管理层面和技术层面的活动，实施中国药物警戒制度符合新法规、新制度的要求。本文将从药物警戒制度的概念和范围、不良反应监测报告制度向药物警戒制度转变的关键点、药物警戒中的各方义务与责任等方面对中国未来的药物警戒制度实施进行讨论与思考。

, authors=张雅娟, 陈慧, 杨悦, authorsList=张雅娟, 陈慧, 杨悦, authorCompany=null, correspAuthors=杨悦, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=horUPZPtyuocduYghYQe9w==, magXml=hmUOw6DJAYcqjcWcRiwyhw==, pdfUrl=null, pdf=Op3dBVFP+OgVmQXAo3aPvQ==, pdfFileSize=1321554, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=qtuRfOoZVCq2Omba9s4v8g==, mapNumber=null, fund=null)}, authors=[Author(id=1322125555273683183, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125553876979944, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhangyajuan@tsinghua.edu.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322125555353374961, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125553876979944, authorId=1322125555273683183, language=EN, stringName=Ya-juan ZHANG, firstName=Ya-juan, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1322125555420483826, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322125553876979944, authorId=1322125555273683183, language=CN, stringName=张雅娟, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=清华大学药学院，北京　100084, bio={"content":"

张雅娟，女，博士，研究方向：药品监管，医院管理等。E-mail：zhangyajuan@tsinghua.edu.cn。

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张雅娟，女，博士，研究方向：药品监管，医院管理等。E-mail：zhangyajuan@tsinghua.edu.cn。

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