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1、DrugMasterFilesCharlesTong,Ph.D.GlobalCMC,PfizerInc.AAPS/CPAWorkshop28-29June2010,Shanghai,China0OutlineDrugMasterFilesintheUSComparisonofUSDMF,EuropeanASMFandCEPRDPACProposalforDMFinChina1DrugMasterFilesintheUSWhataDMFisandisnotTypesofDMFsElectronicfilingandCTD-QAdministrative
2、informationTechnicalinformationbytypeofDMFReviewprocessTechnicalamendmentprocessInteractionbetweenFDAandDMFholderduringDMFreviewIssuesofconcernsfordrugmanufacturersRemarks2WhataDrugMasterFileisandisnotADrugMasterFile(DMF)isasubmissiontoFDAthatmaybeusedtoprovideconfidentialdetai
3、ledinformationaboutfacilities,processes,orarticlesusedinthemanufacturing,processing,packaging,andstoringofoneormorehumandrugsThesubmissionofaDMFisnotrequiredbylaworregulation.ADMFissubmittedsolelyatthediscretionoftheholder.ADMFusuallycoversmanufacturinginformationnotconsideredr
4、eleasableviaaFreedomofInformationAct(FOIA)requestThereareno“Open”and“Closed”partsofaDMF3WhataDrugMasterFileisandisnot(cont’d)TheinformationcontainedintheDMFmaybeusedtosupportanInvestigationalNewDrugApplication(IND),aNewDrugApplication(NDA),AbbreviatedNewDrugApplication(ANDA),an
5、otherDMF,ExportApplication,oramendmentsandsupplementstoanyoftheseADMFisnotasubstituteforanIND,NDA,ANDA,orExportApplicationTechnicalcontentsofaDMFarereviewedonlyinconnectionwiththereviewofanIND,NDA,ANDA,oranExportApplicationDMFisnotapprovedordisapprovedFDAwilldetermineifitstechn
6、icalcontentisacceptableordeficientinsupportoftherelatedapplicationIfdeficient,aletterissent.Ifacceptable,noletterissent.4TypesofDMFs*TypeII:Drugsubstance,drugproduct,intermediates,andmaterialusedintheirmanufactureTypeIII:PackagingmaterialTypeIV:Excipients,colorant,flavor,essenc
7、e,ormaterialusedintheirpreparationTypeV:OtherreferenceinformationacceptedbyFDAe.g.,sterilemanufacturingfacilities,biotechcontractfacilities,clinical,toxicology*TypeIformanufacturingfacilitywaseliminatedinJanuary2000.5ActivevsInactiveDMFsasofJanuary11,2010(Total23,453)9,789Activ
8、e42%Inactive58%13,664NumberofDMFsAsofJanuary11,2010,th
