eCTD-文件的编写与递交

eCTD文件的编写与递交eCTD介绍药品注册法规和计算机相关知识的高度结合FDA：2017年5月5日开始，NDA,ANDA,BLA和MasterFiles文件的递交，IND的递交是从2018年5月5日开始.eCTD介绍ICH3.2.2Current。目前美国、欧盟、日本、加拿大、瑞士、澳大利亚，都接受eCTD提交。ICH4.0标准的eCTD，其specification已经确定，相关国家或地区，正在为下一步实施做紧张准备。4.0和3.2有非常大的不同。eCTD介绍eCTDTemplateTheICHWebsite()includesanemptyeCTDfoldertemplateasanexampleofaneCTDsubmissionfolderstructure.ItshowsallofthepossibleModule2-5andcanbepopulatedwiththeapplicantdataandeditedasappropriate(i.e.,addingadditionalsubfoldersorremovingunnecessaryfolders).TheapplicantshouldstilladdtherelevantregionalModule1foldersandcontent,addtheappropriateutilityfoldersandcontent,andcreatetheXMLindexfilestocompleteavalideCTDsubmission.eCTDSpecificationElectronicCommonTechnicalDocumentSpecificationV3.2.2(PDF)XMLstructureTheeCTDSpecificationisbasedonXMLtechnology.ThespecificationfortheXMLstructureistheDTD.ToensurethattheDTDhasremainedunchanged,useatooltogenerateandcomparetheMD5checksumofyourcopywiththisMD5checksum.AnexampleofsuchatoolisWinMD5(executableforMSWindows).SeeReadme.txtforinstallationinstructions.ThechecksumfortheeCTDDTDis:1d6f631cc6b6357f0f4fe378e5f79a27CommonstylesheetTheM2(ESTRI)ExpertWorkingGrouphasprovidedacommonstylesheet(UpdatedinNovember2004)asreferencedineCTDSpecification,toutilize,savelocallyandcontactyourtechnicalsupportforinstruction.Toensurethatthestylesheethasremainedunchanged,useatooltogenerateandcomparetheMD5checksumofyourcopywiththisMD5checksum.ThechecksumfortheeCTDstylesheetis:3a07a202455e954a2eb203c5bb443f77EmptyfolderstructureAnemptyfolderstructurecanbecreatedusingthisexecutableprogram(forWindowsonly).Thezipfileispasswordprotectedwiththepasswordtemplate.eCTDTemplate(ICH空白模板）各地区Module1的要求eCTDsubmission用到的软件MD5校验Hash_1.0.4StylusStudioAcrobat11updatedENWordLORENZeValidatoreCTD文件递交TheeCTDSubmissionAneCTDsubmissionisacollectionofdataobjectsthatfollowstheeCTDspecification.ThemainfunctionoftheeCTDsubmissionisdataexchange.InformationsystemswouldneedtobedevelopedtoprocesstheeCTDsubmission.ThebiggestbenefitsareexpectedwhentheeCTDsubmissionisloadedintoaninformationsystemthatsupportsthereviewprocess.However,onecanviewaneCTDsubmissionwithaWebbrowserasitisWebready.TheeCTDsubmissioniscomposedofthefollowing:•Directorystructure目录结构•XMLeCTDinstance•ContentfilesDirectorystructure目录结构目录结构包括目录和文件目录和文件的名称应为标示符，应简短，不用表达所有的元数据ICH的建议Directorystructure目录结构XMLeCTDinstancemf999999-0001首次提交举例说明-MODULE1ADMINELEMENTSAdministrativeinformationiscontainedintheadminelement,whichiscontainedinthefda-regional:fda-regionalelement.Theadminelementcontainstwochildelements:applicant-infoapplication-set.Theseelementsshouldbeplacedinorderaslistedbelow.ADMINELEMENTSApplicant-infoElementTheapplicant-infoelementcontainsthefollowingchildelements:id,邓白氏码company-name,submission-description,简单描述andapplicant-contacts.申请人联系方式一个或多个applicant-contact-name,telephones,andemails.举例applicant-contact-typecode-displaystatus=activedisplay=RegulatoryContactcode=fdaact1/code-displaystatus=activedisplay=TechnicalContactcode=fdaact2/code-displaystatus=activedisplay=UnitedStatesAgentcode=fdaact3/code-displaystatus=activedisplay=PromotionalLabelingandAdvertisingRegulatoryContactcode=fdaact4/application-typecode-displaystatus=activedisplay=NewDrugApplication(NDA)code=fdaat1/code-displaystatus=activedisplay=AbbreviatedNewDrugApplication(ANDA)code=fdaat2/code-displaystatus=activedisplay=BiologicLicenseApplication(BLA)code=fdaat3/code-displaystatus=activedisplay=InvestigationalNewDrug(IND)code=fdaat4/code-displaystatus=activedisplay=DrugMasterFile(DMF)code=fdaat5/code-displaystatus=activedisplay=EmergencyUseAuthorization(EUA)code=fdaat6code-displaystatus=activedisplay=InvestigationalDeviceExemption(IDE)code=fdaat7/code-displaystatus=activedisplay=PremarketApprovalApplication(PMA)code=fdaat9/code-displaystatus=activedisplay=PremarketNotification510k(510K)code=fdaat10code-displaystatus=activedisplay=SafetyIssue(FDAUseOnly)code=fdaat8/Application-setElementApplication-informationElementApplication-numberelementapplication-numberapplication-type=fdaat1456789/application-numberCross-reference-application-numberelement…application-numberapplication-type=fdaat1456789/application-numbercross-reference-application-numberapplication-type=fdaat5012345/cross-reference-application-number…Application-setElementSubmission-informationelementa.Submission-idelement-submission-idBelowisanexampleofasubmission-idelementforalabelingsupplementtoanapplication.Thissubmission-idelementalsoincludesthesubmission-typeattributeandthesupplement-effective-date-typeattribute.Inthisexample,thesubmission-idisidentifiedas“0009”(refertosectionIII.B.3.BuildingRegulatoryActivitiesforadditionaldetailsonassigningthecorrectsubmission-idnumbertoeachregulatoryactivity),ithasasubmission-typeattributecodeof“fdast4”:indicatingthatthesubmissiontypeisalabelingsupplement,andithasasupplement-effective-date-typeof“fdasedt2”:indicatingthatitisaCBE-0supplement.…submission-idsubmission-ty