Article(id=1322627653572608985, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, 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=1603123200000, acceptedDateStr=2020-10-20, onlineDate=1793268605845, onlineDateStr=2026-10-29, pubDate=1617033600000, pubDateStr=2021-03-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268605845, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268605845, creator=13701087609, updateTime=1793268605845, updator=13701087609, issue=Issue{id=1322627622589280278, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='6', pageStart='481', pageEnd='576', issueExtLink='null', onlineDate='null', pubDate='1617033600000', pubDateStr='2021-03-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268598458, creator='13701087609', updateTime=1793269229249, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630268373021321, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630268373021322, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627622589280278, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=496, endPage=500, ext={EN=ArticleExt(id=1322627653752964058, articleId=1322627653572608985, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Research on the current regulatory status of FDA on complex generic drugs, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article analyzed the current regulatory situation of FDA on complex generic drugs (nonbiological complex drugs) from two aspects: First, the feasibility of technical evaluation of pharmaceutical equivalence and bioequivalence of complex generic drugs; second, FDA's response strategy to the doubts and challenges of complex generic drugs. The complex generic drugs defined by the FDA contain natural-sourced complex drug substances. The article summarized the FDA's measures using regulatory science to vigorously promote scientific research when facing scientific challenges of complex generic drugs. The methods of promotion include formulating scientific research plans, identifying key research areas, setting up topics, summarizing annual scientific research results, and strengthening communication with the industry. The thoughts of FDA on complex generic drugs may be used as a reference for the technical evaluation of traditional Chinese medicines with the same name and same prescription.

, authors=Yu SUN¹, Gan XU², Qi WANG³, authorsList=Yu SUN, Gan XU, Qi WANG, authorCompany=null, correspAuthors=Gan XU, Qi WANG, 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=1322627653992039387, articleId=1322627653572608985, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=FDA复杂仿制药的监管现状研究, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

本文从两方面对FDA复杂仿制药（非生物复杂药物）的现状进行分析：复杂仿制药的药物等效性、生物等效性技术评价的可行性及FDA面对复杂仿制药质疑和挑战的应对策略。总结了FDA面对复杂仿制药的科学挑战，运用监管科学大力推动科学研究，推动的方式包括制定科学研究计划、确定研究的重点领域、设立课题、总结年度科学研究成果、加强与业界的沟通交流。FDA定义的复杂仿制药包含天然来源的复杂活性成分，其复杂仿制药的研究思路有可能为中药同名同方药技术评价提供参考。

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孙昱，女，博士，主要从事药品政策及技术评价研究。E-mail：sunyu_amber@126.com。

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孙昱，女，博士，主要从事药品政策及技术评价研究。E-mail：sunyu_amber@126.com。

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year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Upcoming Product-Specific Guidances for Complex Generic Drug Product Development[EB/OL]. (2020). https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development., articleTitle=null, refAbstract=null), Reference(id=1322627656391180288, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=LUNAWAT S, BHAT K. Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation[J/OL]. (2020). https://doi.org/10.1007/s43441-020-00114-6., articleTitle=null, refAbstract=null), Reference(id=1322627656466677761, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=United States Government Accountability Office (GAO). GENERIC DRUGS: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs[EB/OL]. (2018). https://www.gao.gov/assets/690/689047.pdf., articleTitle=null, refAbstract=null), Reference(id=1322627656542175234, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives for Fiscal Year 2020[EB/OL]. (2019). https://www.fda.gov/media/132370/download., articleTitle=null, refAbstract=null), Reference(id=1322627656810610692, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. FY2019 GDUFA Research Report: Patient Substitution[EB/OL]. (2020). https://www.fda.gov/media/135187/download#page=1., articleTitle=null, refAbstract=null), Reference(id=1322627656873525253, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. 2019 Office of Generic Drugs Annual Report[EB/OL]. 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Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings[EB/OL]. (2019). https://www.fda.gov/media/130874/download., articleTitle=null, refAbstract=null), Reference(id=1322627657301344264, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627653572608985, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop-Sep. 25-26, 2019[EB/OL]. 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