1028-2c美国药品GMP监管政策介绍王刚

FDA’sInitiativeonDrugQualityFDAsInitiativeonDrugQualityRegulationgThe2014ISPEChinaAnnualAutumnConferenceShenzhen,Oct.28,2014GangWang,Ph.D.(王刚)AssistantCountryDirector(助理主任)FDAChinaOffice(FDA驻华办公室)TheviewsarethoseoftheauthorandTheviewsarethoseoftheauthoranddonotnecessarilyrepresentthoseoftheFDAAgenda•IntroductionFtifOffifPhtilQlit•FormationofOfficeofPharmaceuticalQuality(OPQ)•FDAProgramAlignment•MajorDeficienciesIdentifiedinWarningLettersMajorDeficienciesIdentifiedinWarningLettersIssuedtoChineseFirms2IntroductionIntroduction3AboutFDA•Responsibleforover$2trillioninmedicalproducts,food,cosmetics,dietarysupplementsandtobacco.•FDA-regulatedproductsaccountforabout20FDAregulatedproductsaccountforabout20centsofeverydollarofannualspendingbyUSconsumersU.S.consumers.•Hasapproximately15,700full-timeemployeeslocatedarondtheorldlocatedaroundtheworld.•FY2014budgetis$4.38billion.4OfficeoftheCommissionerOfficeofFoodsOfficeofFoodsandVeterinaryMedicineOfficeofMedicalProducts&TobaccoOfficeofGlobalReg.Ops.&PolicyCenterforFoodSafety&AlidCenterforVeterinaryMedicineCenterforDrugEvaluation&RhCenterforBiologicsEvaluation&RhCenterforDevices&RadiologicalHlthCenterforTobaccoProductsOfficeofRegulatoryAffairsOfficeofInternationalProgramsAppliedNutritionResearchResearchHealth5FDA’sPharmaceuticalQualityfor21stCenturyInitiativeyVisionVision“Amaximallyefficient,agile,flexiblepharmaceuticalmanufacturingsectorthatreliablyproduceshighqualitydrugswithoutextensiveregulatorydrugswithoutextensiveregulatoryoversight.”DrJanetWoodcock–Dr.JanetWoodcock6CtChllCurrentChallengesIncreasingglobalizationofmanufacturingestablishments•IncreasingglobalizationofmanufacturingestablishmentsandchallengestosupplychainsecurityThdftittitfliti•Theneedforpatient–centricassessmentofqualityinachangingworldChllttGDUFAddlifid•ChallengestomeetGDUFAdeadlinesforgenericdrugapplicationsandsupplements•Increasingproductcomplexity•Stateofdrugquality–IncreasedFARs,recalls,drugshortages–LackofusefulqualityindicatorswithintheAgencyandacross-qygyindustry7FormationofOfficeofPharmaceuticalQuality(OPQ)89Current StateCurrent StateFuture StateFuture State10OPQStructure•OPQImmediateOffice–OfficeofProgramandRegulatoryOperationsggyp–OfficeofPolicyforPharmaceuticalQualityOfficeofNewDrugProducts–OfficeofNewDrugProducts–OfficeofLifecycleDrugProducts–OfficeofTesting&Research–OfficeofSurveillance–OfficeofBiotechnologyProductsOfficeofProcessandFacilities–OfficeofProcessandFacilities11OPQMission,Vision,andValuesQlitithdiiQualityistheunderpinningofeverythingwedo.MiiAtht•Mission–AssuresthatqualitymedicinesareavailabletotheAmericanavailabletotheAmericanpublic.•VisionWillbeaglobal•Vision–Willbeaglobalbenchmarkforregulationofpharmaceuticalquality.pqy•Values12OPQValues–OneQualityVoice•Values–Putpatientsfirstbybalancingriskandavailability.–Haveonequalityvoicebyintegratingreviewandinspectionacrossproductlifecycle.–Safeguardclinicalperformancebyestablishingscientifically-soundqualitystandards.–Maximizefocusandefficiencybyapplyingrisk-basedapproaches.–Strengthentheeffectivenessoflifecyclequalityevaluationsbyusingteam-basedprocesses.13OPQValues–OneQualityVoicef–Developandfocusonproductstandards,capturedincriticalqualityattributesandclinically-relevantspecifications.specifications.–Enhancequalityregulationbydevelopingandutilizingstaffexpertise.p–Encourageinnovationbyadvancingnewtechnologyandmanufacturingscience.g–Provideeffectiveleadershipbyemphasizingcross-disciplinaryinteraction,sharedaccountability,andjointproblemsolving.–Buildcollaborativerelationshipsbycommunicatingopenly,honestly,anddirectly.14OfficeofPharmaceuticalQuality•Tobeasingleunitdedicatedtoproductquality•Toprovidebetteralignmentamongalldrugqualityfunctions,includingreview,inspection,andresearch•ToCreateOneQualityVoiceandimproveoversightofqualitythroughoutthelifecycleofadrugproduct•Tocreateauniformdrugqualityprogramacrossallsitesofmanufacture,whetherdomesticorforeign,andacrossalldrugproductareas–newdrugs,genericddOTCddrugs,andOTCdrugs•Tosupportourmissiontoensurethatsafe,effective,hihlitdilblfthAiblihighqualitydrugsareavailablefortheAmericanpublic15DefiningTheme–OneQualityVoiceOneQualityVoiceforD•Drugs•Patients•Industry•HealthcareProfessionalsHealthcareProfessionals•HealthcarePurchasers16DefiningTheme:OneQualityVoice•OneQualityVoiceforDrugs–Centralizequalitydrugreview–creatingonequalityvoicebyintegratingqualityreview,qualityevaluation,andinspectionacrosstheproductlifecycle.Emphasizeonconsistentqualitystandardsandriskbased–Emphasizeonconsistentqualitystandardsandrisk-basedapproachesforreviewingsubmission,evaluatingdrugqualityissues,prioritizinginspections,andgeneratingpolicy.•OneQualityVoiceforPatients–AssurethatqualitymedicinesareavailablefortheAmericanqypublic.–Assurepatientsofqualitydrugsbybalancingpotentialqualityriskswiththeriskofapatientnotgettingadrug.17DefiningTheme:OneQualityVoiceOneQualityVoiceforIndustry•OneQualityVoiceforIndustry–Establishconsistentqualitystandardsandclearexpectationsforindustryforindustry.–CloseinteractionbetweentheOffic