FDA DMF培训

DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DRUGMASTERFILESUNDERGDUFA:DMFBasicsArthurB.Shaw,Ph.D.FDADMFExpertFDASmallBusinessOfficeWebinarFebruary11,2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20132DrugMasterFiles•ADrugMasterFile(DMF)isasubmissionofinformationtotheFDAtopermittheFDAtoreviewthisinformationinsupportofathirdparty’ssubmissionwithoutrevealingtheinformationtothethirdparty.•DMFsusuallycovertheChemistry,ManufacturingandControls(CMC)ofacomponentofadrugproducte.g.drugsubstance,excipient,packagingmaterial.•Drugproductinformationornon-CMCinformationmaybefiledinaDMF.DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20133InformationSources•DMFWebsite–ContainscurrentlistofDMFs,linkstosupportingguidancesand,mostimportantly,adviceforDMFholdersnotinDMFGuidance(1989)Guidancelink:•DMFquestions:–General:[e-mail]–GDUFAspecific:[e-mail]–Technicalquestionse.g.aboutamountofstabilitydataneeded,designationofcompoundasastartingmaterial,[e-mail]:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20134LawsandRegulations•Laws–FoodDrugandCosmeticAct(FD&CAct)–FoodandDrugAdministrationSafetyInformationAct(FDASIA)includingtheGenericDrugUserFeeAct(GDUFA)andPrescriptionDrugUserFeeAct(PDUFA)•Regulations:Section21oftheCodeofFederalRegulations(21CFR)Requiredinformation–314NewDrugApplication(NDA)andAbbreviatedNDA(ANDA)•314.50Contentandformatofanapplication•314.70ChangestoanApprovedApplication•314.420DrugMasterFilesDMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20135Guidances•GuidancedocumentsrepresenttheAgency’scurrentthinkingonaparticularsubject.–DraftGuidancesarepreparedbyFDA,publishedfor“NoticeandComment”intheFederalRegister,andthenfinalizedbyFDA–FDAparticipatesintheInternationalConferenceonHarmonisation(ICH),whichpreparesGuidancesfortheUS,JapanandEurope–Other(usuallyolder)GuidancesareforUS(FDA)only)DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20136RequirementsforaDMFWhoMustFileaDMF?NOBODY•ThereisnolegalorregulatoryrequirementtofileaDMF.InformationcanbeinanApplication(NDAorANDA)ORaDMF.DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20137ReasonsforaDMF•Maintainconfidentialityofproprietaryinformation(e.g.,Manufacturingprocedure)fortheholder•PermitreviewofinformationbyreviewersatFDAtosupportapplicationssubmittedbyoneormoreapplicantsDMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20138ClarificationofsomeTerms•Registration:Inmanypartsoftheworldacompany”Registers”anapplicationora“dossier.”IntheUS,onlymanufacturingsitesare“registered”intheDrugRegistrationandListingSystem(DRLS)•ActivePharmaceuticalIngredient(API)=“drugsubstance.”•LetterofAccess:InsomecasesaDMFholderwillcallthepermissiontoreferenceaDMFa“LetterofAccess.”(PhraseusedinEurope).IntheUS,thisiscalleda“LetterofAuthorization”(LOA).AnLOAdoesnotpermitanyoneexceptFDAto“Access”i.e.“read”theDMF•TransmittalLetter=CoverLetter•AnnualReport=AnnualupdateDMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar20139InitialSubmission-PaperDMFs•HoldersendstheDMFintwocopiestoCentralDocumentRoomCenterforDrugEvaluationandResearch5901-BAmmendaleRoadBeltsville,MD20705-1266•Userecommendedbinders•Fastenersmustbeobtainedseparately.2PieceProngFasteners,81/2CentertoCenter,31/2CapacityDMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar201310•ElectronicSubmissionGateway(ESG)–HoldersendstheDMFinElectronicCommonTechnicalDocument(eCTD)formatthroughtheESG–ChooseCDERastheCenterandeCTDasthesubmissiontype•PhysicalMedia(CD-ROM,DVDorUSBdrive)–HoldersendstheDMFonphysicalmediumineCTDformattotheaddressonpreviousslide–SeetheTransmittingSpecificationswebsitewhentransmittingviaphysicalmedia(CD\DVD)–•AcceptanceofdigitalsignaturesthesameasforanyothersubmissiontoFDAInitialSubmission–ElectronicDMFsDMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar2013DMFsUnderGDUFA:DMFBasicsSmallBusinessWebinar201311•GuidanceFollowtheDMFGuidanceandadditionalinformationonDMFWebsite.(SeeSlide3)•Pre-assignedNumberApre-assignednumb