Article(id=1291339235294961901, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339070622396983, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.03.030, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1724083200000, receivedDateStr=2024-08-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808865616, onlineDateStr=2026-08-04, pubDate=1739721600000, pubDateStr=2025-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808865616, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808865616, creator=13041195026, updateTime=1785808865616, updator=13041195026, issue=Issue{id=1291339070622396983, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1739721600000', pubDateStr='2025-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808826353, creator='13041195026', updateTime=1785808826353, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=445, endPage=450, ext={EN=ArticleExt(id=1291339236209320174, articleId=1291339235294961901, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research and consideration on regulatory strategies for fecal microbiota products in different countries, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

In recent years, fecal microbiota for transplantation (FMT) has developed rapidly as a potential intervention for numerous conditions that may be caused by gut microbiota disorders and there are fecal microbiota products (FMP) have been approved to treat recurrent Clostridioides difficile infection (rCDI). There is currently no unified positioning and regulatory measures for FMP internationally, which poses challenges for the development of such products. This article proposes several thoughts on the regulation and evaluation of FMP based on reviewing the regulatory strategies of different countries for FMP and the research and regulatory situation of approved products, in order to provide reference for the development and application of such products.

, authors=Hua-jing YIN¹, Yi-fei CHEN^{2, 3}, Mao-shan YIN¹, Tao SUN¹, authorsList=Hua-jing YIN, Yi-fei CHEN, Mao-shan YIN, Tao SUN, authorCompany=null, correspAuthors=Tao SUN, 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=1291339236997849327, articleId=1291339235294961901, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=不同国家粪菌产品的监管策略研究及思考, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

近年来，粪菌移植（FMT）作为新的治疗手段发展迅速，正被开发用于治疗肠道微生物群紊乱可能导致的多种不同的疾病，且已有粪菌产品（FMP）获批上市用于治疗复发性艰难梭菌感染（rCDI）。目前国际上对FMP尚无统一的定位和监管措施，为此类产品的开发带来挑战。本文通过梳理不同国家对FMP的监管策略和已上市产品的研究、监管情况，提出对FMP监管和评价的几点思考，以期为此类产品的研发和应用提供参考。

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尹华静（1989-），女，副主任药师，主要从事药品非临床技术审评工作

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尹华静（1989-），女，副主任药师，主要从事药品非临床技术审评工作

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