上海CMC培训 Overview of Regulatory Framework and CMC Requirements in the US

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1、OverviewofRegulatoryFrameworkandCMCRequirementsintheUSrichard.poska@abbott.comGlobalPharmaceuticalRegulatoryAffairsCMCRequirementsandStrategiesWorkshop28June20101PoskaCMCOverview062810PresentationGoalsExploretheroleofscienceinFDAandICHpolicyReviewFDAregulatoryCMCsubmissionreq

2、uirementsandexpectationsOutlineFDAsubmissionreviewprocessandoutcomesSummarizescience/riskbasedapproachedtoCMCsubmissionsImpactofcollaborativepartnerships:Industry,academia,andFDA2PoskaCMCOverview062810Theonewhomovesamountainbeginsbycarryingsmallstones.3PoskaCMCOverview062810U

3、SDrugRegulationMilestones1820UnitedStatesPharmacopeiaestablished1906Food&DrugsActInterstateCommerce,Adulterated,MisbrandedDrugs1937Sulfanilamide/DiethyleneGlycol1938FD&CAct(FD&CA)passedSafetydata&FactoryInspections1962ThalidomideKefauver-Harrisamendments-efficacy4PoskaCMCOver

4、view062810FrameworkforUSPharmaceuticalRegulationLaws&RegulationsReviewPublicStandardsCompliance5PoskaCMCOverview0628106PoskaCMCOverview062810USManufacturingChanges–25YearsagoPriorapprovalperFD&CActMagnitudeofManufacturingChangeIntrinsicRiskofMolecule7PoskaCMCOverview062810T

5、heValueofGuidances8PoskaCMCOverview062810CMCRequirements-PostApprovalCategoriesforreportingchangeisgaugedonpotentialforadverseeffects:Major(PriorApproval)SubstantialpotentialModerate(CBE)ModeratepotentialMinor(AR)Minimalpotential9PoskaCMCOverview062810USManufacturingChanges-T

6、odayPriorapprovalperFDAMAAllotherchangesARperPACRegulations&GuidancesMagnitudeofManufacturingChangeIntrinsicRiskofMolecule10PoskaCMCOverview062810DesiredStatePriorapprovalperFDAMAARperPACMagnitudeofManufacturingChangeIntrinsicRiskofMoleculeHIGHRISKMolecular/ProductClinicalExp

7、erienceGMPIssuesProcessUnderstandingQbDLOWRISKControlStrategiesPAT11PoskaCMCOverview062810GeneralCharacteristicsof“Traditional”GuidancesPrescriptive(expectationsandrequirementsdefined)AllowsdefinedflexibilityHelpsbothregulatorsandindustryfocusondetailsContributestouniformint

8、erpretationandlevel“playingfield”forall12PoskaCMCOverview062810Guida