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ThisguidelineprovidesinformationonthecontentsoftheSouthAfricanCTDModuleAdministrativeInformationasModuleisregionspecificTheCommon TechnicalDocument(CTD)wasdesignedtoprovideacommonformatbetweenEurope,USA,andJapanforthetechnicaldocumentationincludedinan applicationfortheregistrationofahumanpharmaceuticalproducteCTDThisguidelinedescribesaCTDformatthatwillsignificantlyreducethetimeand resourcesneededtocompileapplicationsforregistrationandinthefuture,willeasethepreparationofelectronicdocumentalsubmissionsForsubmitting applicationsonCTDformat,applicantneedstofollowthefollowinggeneralinstructions/guidancetoensurepropersubmissionModule(Administrativepart)shallbe preparedasprovidedinForm-5FwithoutdeletinganycomponentInthecentralisedprocedure,thiswillbeequivalenttoalldosageformsandstrengthscovered byanEMAapplicationnumber(egTheCommonTechnicalDocument(CTD)formatordossierwasdesignedbytheICHandwasagreeduponasacommon formatbetweenthreemajorregulatoryregions,i.e.Applicantshallmention“Notapplicable”withproperjustificationforthosepartsWhatistheCommon TechnicalDocument(CTD)?TheElectronicCommonTechnicalDocument(eCTD)allowsfortheelectronicsubmissionoftheCommonTechnicalTypically,an eCTDapplicationwillcoveralldosageformsandstrengthsofaproductEachapplicationisacollectionofdocumentsgroupedintomodulesasdetailedbelow LiaisingwiththenationalregulatoryauthorityTheCTDiscurrentlyonlyapplicabletohuman,notveterinary,medicinesInMRP/DCP,asingleeCTDapplication shouldpreferablybeusedfortheprocedureTheeCTDBackboneFileSpecificationforModules(PDFMB)AddendumtotheeCTDBackboneFiles SpecificationForModuleVersion(PDFKB)AddendumtotheeCTDBackboneFilescommontechnicaldocument(eCTD)forModulesthroughprovidingdirection ontheappropriateformatforthedatathathavebeenacquiredTheCTDmustbewrittenentirelyinEnglishandprovidedineitherMicrosoftWordorPDF electronic,searchableversions.EMEA/H/C/).ApplicantsshouldnotmodifytheTheeCTDistheelectronicequivalenttotheCTD.“TheeCTDisdefinedasan interfaceforindustrytoagencytransferofregulatoryinformationwhileatthesametimetakingintoconsiderationthefacilitationofthecreation,review,lifecycle managementandarchivaloftheelectronicsubmission”products,theACTDformatisalsoapplicableforbiosimilarproductsTheactualcontentofthedossierwill varyaccordingtotheapplicationcategoryandapplicationtypeAccordingtotheCTDformat,eachapplicationisacollectionofdocuments,groupedintomodules TheformatandcontentofModulearedescribedinthisdocumentKeywords:Commontechnicaldocument(CTD),dataformatCurrenteffectiveversionICH guidelineM4(R4)oncommontechnicaldocument(CTD)fortheregistrationofpharmaceuticalsforhumanuseorganisationofCTDStep5Organizationofthe CommonTechnicalDocumentfortheRegistrationofPharmaceuticalsforHumanUseTheguidanceprovidesrecommendationsontheorganizationoftheCTD andtheelectronicElectronicCommonTechnicalDocumentSpecificationV(PDF)ThisspecificationhasbeendevelopedbytheICHM2EWGandismaintained bytheM8eCTDEWG/IWGinaccordancewiththeICHProcess,aswellastheeCTDchangecontrolXMLBasedeCTDTheXMLeCTDDTD(Document TypeDefinition)definestheoverallstructureofthesubmissionThepurposeoftheXMLbackboneistwo-fold:(1)tomanagemeta-datafortheentiresubmission andeachThisElectronicCommonTechnicalDocument(eCTD)TechnicalConformanceGuide(Guide)•PortableDocumentFormat(PDF)Specifications ExampleSubmissionsusingeCTDv4specificationsUndertheCTDformat:HowtoaccessapdfdocumentEuropeanUnion(EU),USA,andJapanfor submissionoftechnicaldocumentationincludedinanapplicationfortheregistrationIndexingPDFDocumentsstandardizetheelectronicformatofthecommon partsoftheeCTD.