CTD格式介绍(中英文对照)

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE人用药物注册技术要求国际协调会议ICHHARMONISEDTRIPARTITEGUIDELINEICH三方协调指南THECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:人用药物注册通用技术文件QUALITY质量QUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITY模块2：质量概要模块3：质量HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHICH指导委员会会议ICH进程第4步2000年11月9日该指南建议三方法规处采用ICH(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.该指南已经合格的专家工作组研究并按照ICH程序经法规部协商。进程第4步最终草案已被欧盟、日本和美国采纳iTHECOMMONTECHNICALDOCUMENTFORTHEREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE:人用药物注册通用技术文件QUALITY质量QUALITYOVERALLSUMMARYOFMODULE2MODULE3:QUALITY模块2：质量概要模块3：质量ICHHARMONISEDTRIPARTITEGUIDELINEICH三方协调指南HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH(NumberingandSectionHeadershavebeeneditedforconsistencyanduseine-CTDasagreedattheWashingtonDCMeeting,September11-12,2002)ICH指导委员会会议ICH进程第4步2000年11月9日该指南建议三方法规处采用ICH2002年9月11-12日华盛顿会议一致通过采用统一编号和标题并在e-CTD中使用TheCommonTechnicalDocument-QualityiiTABLEOFCONTENTS目录MODULE2:COMMONTECHNICALDOCUMENTSUMMARIES................................62.3:QUALITYOVERALLSUMMARY(QOS)......................................................................6INTRODUCTION.........................................................................................................................62.3.SDRUGSUBSTANCE(NAME,MANUFACTURER)....................................................62.3.S.1GeneralInformation(name,manufacturer).....................................................62.3.S.2Manufacture(name,manufacturer)..................................................................72.3.S.3Characterisation(name,manufacturer)...........................................................72.3.S.4ControlofDrugSubstance(name,manufacturer)...........................................82.3.S.5ReferenceStandardsorMaterials(name,manufacturer)...............................82.3.S.6ContainerClosureSystem(name,manufacturer)............................................92.3.S.7Stability(name,manufacturer).........................................................................92.3.PDRUGPRODUCT(NAME,DOSAGEFORM).............................................................92.3.P.1DescriptionandCompositionoftheDrugProduct(name,dosageform)........92.3.P.2PharmaceuticalDevelopment(name,dosageform).........................................92.3.P.3Manufacture(name,dosageform).....................................................................92.3.P.4ControlofExcipients(name,dosageform).....................................................102.3.P.5ControlofDrugProduct(name,dosageform)................................................102.3.P.6ReferenceStandardsorMaterials(name,dosageform)................................102.3.P.7ContainerClosureSystem(name,dosageform)............................................102.3.P.8Stability(name,dosageform)..........................................................................102.3.AAPPENDICES..................................................................................................................122.3.A.1FacilitiesandEquipment(name,manufacturer)...........................................122.3.A.2AdventitiousAgentsSafetyEvaluation(name,dosageform,manufacturer)................................................................122.3.A.3Excipients.........................................................................................................122.3.RREGIONALINFORMATION.......................................................................................12MODULE3:QUALITY...................................................................................................133.1.TABLEOFCONTENTSOFMODULE3........................................................................133.2.BODYOFDATA.................................................................................................................133.2.SDRUGSUBSTANCE(NAME,MANUFACTURER)..................................................133.2.S.1GeneralInformation(name,manufacturer)...................................................13TheCommonTechnicalDocument–Qualityiii3.2.S.1.1Nomenclature(name,manufacturer)......................................................143.2.S.1.2Structure(name,manufacturer)..............................................................153.2.S.1.3GeneralProperties(name,manufacturer)..............................................153.2.S.2Manufacture(name,manufactu