美国FDA药品标签法规要求

U.S.FoodandDrugAdministrationNotice:ArchivedDocumentThecontentinthisdocumentisprovidedontheFDA’swebsiteforreferencepurposesonly.Itwascurrentwhenproduced,butisnolongermaintainedandmaybeoutdated.1ImportationofActivePharmaceuticalIngredient(API)RequirementsBillNychisActingTeamLeaderUSFDACenterforDrugEvaluationandResearch(CDER)OfficeofCompliance(OC)DivisionofNewDrugLabeling&Compliance(DNDLC)Import-ExportTeam7/16/08NewYorkAPISeminar2Requirements:Overview„GENERALIMPORTATION:Definitions„REGISTRATIONANDLISTING:FRN„APIEXEMPTIONS„MISBRANDING:LabelingRequirements&Exemptions„MARKETING:Requirements&UsefulInformation„OTC,PharmacyCompounding,Pre-SubmissionBatches,andRx„DATABASE:DrugMasterFiles(DMFS)/EstablishmentEvaluationSystem(EES)„PRE-LAUNCHACTIVITIESIMPORTATIONREQUEST(PLAIR)„CONTACTS3Definition:“Drug”[FFD&CAct201(g)(1)]„Articlesintendedtodiagnose,cure,mitigate,treatorpreventdiseaseinmanorotheranimals„Articles(otherthanfood)intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals„Articlesintendedforuseasacomponentofadrug4Definition:Newdrug[201(p)]„anydrug....thecompositionofwhichissuchthatsuchdrugisnotgenerallyrecognized,amongexpertsqualifiedbyscientifictrainingandexperience....,assafeandeffectiveforuseundertheconditionsprescribed,recommendedorsuggestedinthelabeling.„A“newdrug”mustbecoveredbyanapprovednewdrugapplication(NDA/ANDA)tobemarketedintheU.S.orbyaninvestigationalnewdrugapplication(IND)[505]„AppliestobothRxandOTCdrugs5Definition:Over-the-counterdrugproducts(OTC)„AllotherdrugsthatcanbeusedsafelywithoutmedicalsupervisionExamples:„Medicationsforfeversuchasaspirinandacetaminophen„Preparationsforthecommoncoldorallergies„Antacids,and„Somefirstaidantibiotics6Definition:Prescription(Rx)drugproducts[503(b)(1)]„ThesedrugscannotbeusedsafelywithoutmedicalsupervisionExamples:„Injectabledrugsor„drugstotreatseriousconditionslikeheartdisease,cancer,orfertilityproblems7Definition:APIa.k.a.bulkdrugsubstance[21CFR207.3]„anysubstancethatisrepresentedforuseinadrugandthat,whenusedinthemanufacturing,processing,orpackagingofadrug,becomesanactiveingredientorafinisheddosageformofthedrug“„termdoesnotincludeintermediatesusedinthesynthesisofsuchsubstance8Definition:Misbranding-AdequateDirectionsforUse[502(f)(1)&21CFR201.5]„“directionsunderwhichalaymancanusethedrugsafely…”9Registration&ListingRequirementsforForeignEstablishments:„FFD&CActSection510(i)[21U.S.C.360]„21CFR207.40„FFD&CActSection502(o)[21U.S.C.352]„FFD&CActSection801(o)[21U.S.C.381]10Registration&ListingForeignfirmsthatmanufacture,prepare,propagate,compound,orprocessadrugimportedorofferedforimportintotheU.S.arerequiredto:1.Registernameandplaceofbusiness2.ListalldrugsimportedorofferedforimportintotheU.S.3.DesignateaU.S.Agent11Registration&ListingRequirementsapplyto…„ManufacturersoffinishedproductsandAPIs„Repackers„Relabelers„Controllaboratories(registrationonly)„Domesticfacilitiesthatmanufacture,pack/repack,label/relabel,etc.drugsundertheImportforExport(IFE)provisions[801(d)(3)](registrationonly)12Registration&Listing„Registrationmustberenewedannually„Registrationrequiredbeforeanyapplicationisapproved„Listinginformationmustbeupdated:„EveryJuneandDecemberor„Discretionoftheregistrantor„Whenanychangeoccurs13Registration&Listing:U.S.AgentnEachforeigndrugestablishmentmustdesignateonlyoneUnitedStatesagentnMustbephysicallylocatedintheU.S.nPointofcontactbetweenFDAandforeignfirmonalldrugregistration&listingmattersandrequirements14Registration&Listing:U.S.AgentLetterofdesignationmust:nBepreparedontheforeignfirm'sletterheadnBesignedbyauthorizingofficialofthefirmnContainthefollowing:nNameofthefirm'sdesignatedU.S.AgentnAddressnTelephone/faxnumbers,andnE-mailaddress15Registration&ListingNationalDrugCodeNumber(NDC#):„Assignedtoeachlistedproduct„Identifiesmanufacturer/distributor,drug,andtradepackagesize/type„FDArequestsbutdoesnotrequiredtoappearontheproductlabelorlabeling:-IftheNDC#appearsonthelabelitmustcomplywith21CFR207.35(b)(3)„DoesnotindicateFDA’sapprovalofafirmoritsproducts16Registration&ListingTheBioterrorismActof2002:RequiresforeigndrugestablishmentswhosedrugsareimportedintotheU.S.tosubmitcertaininformationwiththeannualregistration(Thisisinadditiontotheregularregistrationrequirements):„Eachimporter/consigneeofeachdrugintheU.S.knowntothemanufacturerattimeofregistration„Eachpersonwhoimportsorofferstoimportthemanufacturer’sdrugs„ThenameandcontactinformationofU.S.Agent17Registration&Listing„Non-listedproductsaremisbranded[502(o)]andinviolationof801(a)(3)„Firmsthatarenotincompliancewith510(i)areinviolationof801(o)18Listing-Exemptions„Inactiveingredients„Intermediates(non-API)„DrugproductsnotforimportationintotheU.S.„DrugsimportedorofferedforimportunderanInvestigationalNewDrugApplication(IND)[21CFR312]„ComponentsofdrugsimportedunderSection801(d)(3)-ImportforExport(IFE)19RegistrationandListingInformation„FDAForms:„NDCDirectory:„GuidanceAnnualRegistration:„AnnualRegistrationStatus: