FDA-eCTD申报指南(中英文)

FDAeCTD申报指南（中英文）本次修订内容：January2019SectionI.Introduction•ParagraphaddeddescribingrationaleforextendingtimetableforTypeIIIdrugmasterfilesubmissionsineCTDforanadditional12months.SectionIII.B.TimetableforImplementationofElectronicSubmissionRequirements•UpdatedtoreflectthattherequirementforTypeIIIdrugmasterfilestobefiledelectronicallytakesplace60monthsafterMay5,2015.•Exampleoftimetableupdatedtoreflectactualtimetablefortheimplementationoftheelectronicsubmissionsrequirement.2019年1月第I部分.前言•增加段落说明III类DMF文件以eCTD格式申报的时间表延迟12个月的理由第III.B部分.电子提交要求实施时间表•更新以反映III类DMF电子提交要求将在2015年5月5日之后60个月实施•更新时间表以反映电子申报要求的实际实施时间表ProvidingRegulatorySubmissionsinElectronicFormat—CertainHumanPharmaceuticalProductApplicationsandRelatedSubmissionsUsingtheeCTDSpecificationsGuidanceforIndustry行业指南：使用eCTD标准采用电子格式提交注册申报—特定人药申报和相关申报资料I.INTRODUCTION前言Undersection745A(a)oftheFederalFood,Drug,andCosmeticAct(FD&CAct),atleast24monthsaftertheissuanceofafinalguidancedocumentinwhichtheFoodandDrugAdministration(FDA)hasspecifiedtheelectronicformatforsubmittingsubmissiontypestotheAgency,suchcontentmustbesubmittedelectronicallyandintheformatspecifiedbyFDA.ThisguidanceandthetechnicalspecificationdocumentsitincorporatesbyreferencedescribehowsponsorsandapplicantsmustorganizethecontentthattheysubmittotheAgencyelectronicallyforallsubmissiontypesundersection745A(a)oftheFD&CAct.Inadditiontothisguidanceandexistingtechnicalspecificationdocuments,furtherandmoredetailedtechnicalinstructionsareincludedinaseparateeCTDtechnicalconformanceguide.根据FDCA第745A(a)条款，在发布FDA指定电子格式提交申报文件的最终指南文件之后最短24个月，此类申报必须采用电子方式按FDA指定的格式提交。本指南及其参考文件中包括的技术标准文件阐明了承办人和申报人必须以何方式组织其将以电子格式提交给FDA的依据FDCA第745A(a)条款制作的所有申报类型资料内容。除了本指南和已有技术标准文件外，在另一份单独的eCTD技术合规指南中包括有更多更详细的技术指导。Thisguidanceimplementstheelectronicsubmissionrequirementsofsection745A(a)oftheFD&CActfortheelectronicformatofthecontentsubmittedinnewdrugapplications(NDAs),abbreviatednewdrugapplications(ANDAs),certainbiologicslicenseapplications(BLAs),andcertaininvestigationalnewdrugapplications(INDs)totheCenterforDrugEvaluationandResearch(CDER)ortheCenterforBiologicsEvaluationandResearch(CBER).SeesectionIII.Aofthisdocumentformoreinformationregardingrequiredsubmissiontypes.SubmissionsthatarenotsubmittedelectronicallyandelectronicsubmissionsthatarenotinaformatthatFDAcanprocess,review,andarchivewillnotbefiledorreceived,unlessexemptedfromtheelectronicsubmissionrequirements.本指南执行的是FDCA第745A(a)条款的电子申报要求，其适用于向CDER和CBER提交的NDA、ANDA、特定BLA和特定IND中提交的内容的电子格式。关于申报类型要求更多信息参见本文件第III.A部分。除免除电子申报要求者外，凡采用FDA不可处理、审核和归档的格式提交的电子申报资料和非电子格式提交的申报资料将被拒收或拒绝立卷。TheversionofthisguidancepublishedonMay5,2015providedatimetableof24monthsafterissuanceofthefinalguidancefortheinitialimplementationoftheelectronicsubmissionrequirementforNDAs,ANDAs,BLAs,andmasterfiles,and36monthsforcommercialINDs.ThetimetableindicatedthatNDAs,BLAs,ANDAs,andmasterfilesweretobesubmittedelectronicallyineCTDformatstartingonMay5,2017(May5,2018forcommercialINDs).2015年5月5日发布的本指南版本中的有一个时间表，要求在签发最终指南之后24个月NDA、ANDA、BLA和主文件开始实施电子申报要求，商业IND在签发后36个月实施。时间表显示NDA、BLA、ANDA和主文件自2017年5月5日开始以eCTD格式提交。FDAdetermined,inresponsetoindustrycommentsandinternalreview,thatitwasappropriatetoextendtherequireddatetosubmitmasterfilesinelectroniceCTDformatby1yeartoMay5,2018.Amongotherfactors,FDArecognizedthattherewerechallengeswithsubmissionofmasterfilesineCTDformat,andeCTDuptakedataformasterfilesindicatedthatadheringtotheMay5,2017datecouldhaveledtohighrejectionratesofmasterfilesandthusslowerFDAreviewprocesses,and,therefore,potentialunnecessarydelayinthereviewofsomedrugapplications.为响应企业建议和内部审核，FDA决定适当延后以eCTD格式提交DMF的时间一年至2018年5月5日。除了其它因素外，FDA亦认识到以eCTD格式提交DMF具有挑战性，DMF的eCTD提取数据显示坚持要求2017年5月5日执行该要求可能会导致超高DMF拒收，因此拖慢FDA的审评流程，从而不必要地延迟一些制剂申报资料的审评。Followingthepublicationofthatrevision,FDAdeterminedthatapplicationoftheelectronicsubmissionrequirementtoTypeIIIdrugmasterfiles(DMFs)onMay5,2018couldleadtohighrejectionratesofthesesubmissions.Further,becauseTypeIIIDMFstypicallyprovideinformationregardingpackagingorpackagingmaterialsinsupportofNDAs,ANDAs,orBLAs,shouldsubmitterschoosenottosubmitortonolongersupportexistingTypeIIIDMFs,thiscouldleadtodrugsupplyinterruptions.Finally,onlyasmallportionofTypeIIIDMFssubmittedtotheAgencyrequireassessmentbyFDAstaffinsupportofamarketingapplication;inmostcases,theinformationneededtosupportapprovalisalreadypresentinthemarketingapplication.Giventhis,theburdenontheAgencyofallowingnon-eCTDsubmissionsforTypeIIIDMFsduringtheinterimperiodwasexpectedtobelow.FDAhascontinuedtorecommenduseoftheeCTDformatforTypeIIIDMFswherepossible,buttheAgencyissuedarevisiontothisguidancetoextendtheimplementationdateforTypeIIIDMFsuntilMay5,2019.Sincepublicationofversion5,whichextendedtheimplementationdatetoMay5,2019,FDAdeterminedthatmanyoftheconcernsoutlinedaboveremain.Therefore,theAgencyisissuingarevisiontothisguidancetofurtherextendtheimplementationdateforTypeIIIDMFsuntilMay5,2020.在该次修订发布后，FDA认为III类DMF电子申报要求如果在2018年5月5日实施，可能会导致该类申报较高的拒收率。另外，由于III类DMF一般提供的是支持NDA、ANDA或BLA的包装或包材信息，如果申报者选择不再提交或不再支持现有III类DMF，则可能会导致药品供应中断。最后，在提交给FDA的III类DMF文件中只有少量资料