M4Q指导原则-CTD和QOS的模板

EuropeanMedicinesAgency7WestferryCircus,CanaryWharf,London,E144HB,UKTel.(44-20)74188575Fax[phone]E-mail:[e-mail]EMEA2006Reproductionand/ordistributionofthisdocumentisauthorisedfornoncommercialpurposesonlyprovidedtheEMEAisacknowledgedJuly2003CPMP/ICH/2887/99-QualityICHTopicM4QCommonTechnicalDocumentfortheRegistrationofPharmaceuticalsforHumanUse-QualityStep5COMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEQUALITYOVERALLSUMMARYOFMODULE2ANDMODULE3:QUALITY(CPMP/ICH/2887/99-Quality)TRANSMISSIONTOCPMPJuly2000RELEASEFORCONSULTATIONJuly2000DEADLINEFORCOMMENTSSeptember2000TRANSMISSIONTOCPMPFORINFORMATIONNovember2000RELEASEFORINFORMATIONNovember2000NUMBERINGANDSECTIONHEADERSEDITEDFORCONSISTENCYANDUSEINE-CTDASAGREEDBYICHSTEERINGCOMMITTEESeptember2002TRANSMISSIONTOCPMPANDRELEASEFORINFORMATIONFebruary2003DATEFORIMPLEMENTATIONJuly2003Note:ThesequenceofM4CommonTechnicalDocumentfortheRegistrationofPharmaceuticalsforHumanUseis:M4-OrganisationofCommonTechnicalDocumentM4Quality-QualityoverallsummaryofModule2andModule3:QualityM4Safety-NonclinicalOverviewandNonclinicalSummariesofModule2andOrganisationofModule4M4Efficacy-ClinicaloverviewandClinicalsummaryofModule2andModule5:ClinicalStudyreports©EMEA20062Thedocumentaspresentedmaybesubjecttofurthereditorialchangesandisforinformationonly.DetailsonhowtoprepareasubmissiondossierbasedontheCTDformatincludinginformationonthecontentofModuleIareincludedintherevisionoftheNoticetoApplicants.©EMEA20063COMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:QUALITYQUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITYTABLEOFCONTENTSMODULE2:COMMONTECHNICALDOCUMENTSUMMARIES.................................72.3:QUALITYOVERALLSUMMARY(QOS).......................................................................7INTRODUCTION.........................................................................................................................72.3.SDRUGSUBSTANCE(NAME,MANUFACTURER).....................................................72.3.S.1GeneralInformation(name,manufacturer)...............................................................72.3.S.2Manufacture(name,manufacturer)...........................................................................72.3.S.3Characterisation(name,manufacturer).....................................................................82.3.S.4ControlofDrugSubstance(name,manufacturer).....................................................82.3.S.5ReferenceStandardsorMaterials(name,manufacturer)..........................................82.3.S.6ContainerClosureSystem(name,manufacturer)......................................................82.3.S.7Stability(name,manufacturer)..................................................................................82.3.PDRUGPRODUCT(NAME,DOSAGEFORM)..............................................................82.3.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform).................82.3.P.2PharmaceuticalDevelopment(name,dosageform)..................................................92.3.P.3Manufacture(name,dosageform).............................................................................92.3.P.4ControlofExcipients(name,dosageform)...............................................................92.3.P.5ControlofDrugProduct(name,dosageform)..........................................................92.3.P.6ReferenceStandardsorMaterials(name,dosageform)............................................92.3.P.7ContainerClosureSystem(name,dosageform).......................................................92.3.P.8Stability(name,dosageform)...................................................................................92.3.AAPPENDICES.....................................................................................................................92.3.A.1FacilitiesandEquipment(name,manufacturer)........................................................92.3.A.2AdventitiousAgentsSafetyEvaluation(name,dosageformandmanufacturer).....................................................................92.3.A.3Excipients................................................................................................................102.3.RREGIONALINFORMATION........................................................................................10MODULE3:QUALITY...........................................................................................................113.1.TABLEOFCONTENTSOFMODULE3........................................................................113.2.BODYOFDATA...............................................................................................................11©EMEA200643.2.SDRUGSUBSTANCE(NAME,MANUFACTURER)...............................................113.2.S.1GeneralInformation(name,manufacturer).............................................................113.2.S.1.1Nomenclature(name,manufacturer)...............................................................113.2