Article(id=1236369019742253792, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369011668210230, 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=1673971200000, acceptedDateStr=2023-01-18, onlineDate=1772702944931, onlineDateStr=2026-03-05, pubDate=1692028800000, pubDateStr=2023-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702944931, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702944931, creator=13701087609, updateTime=1772702944931, updator=13701087609, issue=Issue{id=1236369011668210230, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='15', pageStart='1489', pageEnd='1592', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702943007, creator=13701087609, updateTime=1772703232203, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236370224711258643, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369011668210230, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236370224711258644, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369011668210230, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1514, endPage=1522, ext={EN=ArticleExt(id=1236369019998106351, articleId=1236369019742253792, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Knowledge map study of drug regulatory science research in China: based on journal literature of CNKI, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Excel and Cite Space were used to perform bibliometrics and knowledge map study of relevant literature from 1983 to 2021 in the field of drug regulatory science of CNKI in China. Research status and development trends are analyzed from the annual amount of articles, literature sources, foundation, research hotspots and research subjects. The study finds that by 2021, drug regulatory science research in China has reached a certain scale, with the number of articles increased rapidly. The number of publications in core journals have began to increase, and 33.89% of the articles were supported by the fund. Research hotspots focused on two aspects: pharmacovigilance with its related systems, and new methods and technologies of drug regulation. A network of collaboration has been formed among major researchers and research institutions, with close cooperation among universities, medical institutions, and government agencies. However, a certain geographical restriction existed in the cooperation. To promote the healthy and rapid development of drug regulatory science research in China, it is necessary to improve the quality of published research results, deeply dig the frontier research directions, and encourage international-domestic exchanges and collaboration. At the same time, it is also important to break the regional cooperation barriers in current research network, mobilize the enthusiasm of medical enterprises, and widen the cooperation among medical enterprises, universities, medical institutions, and government agencies.

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通过Excel和Cite Space软件对中国知网中我国药品监管科学领域1983—2021年文献进行文献计量及知识图谱分析，从文献年发文量、文献来源、基金资助、研究热点及研究主体5个方面进行研究现状及发展趋势剖析。研究发现截至2021年我国药品监管科学研究已形成一定规模，文献数量快速增加，核心期刊载文数量开始上升，33.89%文献受到基金支持。研究热点主要围绕药物警戒及其相关体系和药品监管新方法、新技术两大方面进行。该领域主要研究者及研究机构初步形成合作网络，高校、医疗机构及政府机关间合作密切，合作研究受到一定的地域限制。为了促进我国药品监管科学研究健康快速发展，应注重提升研究成果发表质量，深入挖掘前沿热点研究方向，积极推进国际国内交流合作，同时打破现有研究网络中的地域合作壁垒，调动医药企业积极性，增加医药企业与高校、医疗机构及政府机关间的合作。

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闵霄琪，女，本科，主要从事药品监管科学与药物警戒研究。E-mail: mxq2023@163.com。

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闵霄琪，女，本科，主要从事药品监管科学与药物警戒研究。E-mail: mxq2023@163.com。

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