艾昆纬-Generics弥合制药和东盟市场的监管差距（英）-2024.2-12页

WhitePaperGenerics:BridgingtheRegulatoryGapinPharmergingandASEANMarketsExploringtrendsandpoliciesinfluencinggenericswhilenavigatingregulatorychallengesWANGXUEYINGSHERRY,Principal,HeadofCommercialRegulatoryServicesWANGKAIYE,Consultant,CommercialRegulatoryServicesFREDERICKSIM,Consultant,CommericalRegulatoryServicesTableofcontentsIntroduction2Generics:Importanceandmarkettrends2Policiesandinterventions3Barriers3IntellectualProperty(IP)protection3Bioequivalence(BE)assessment5Country-specificconsiderations5Conclusionandrecommendations7References8Abouttheauthors10IntroductionOntheregulatoryfront,combinedeffortsbytheInternationalCouncilforHarmonisationofTechnicalTheincreasingandcontinueduseofgenericsinbothRequirementsforPharmaceuticalsforHumanUse(ICH)developedanddevelopingeconomiessignifiesaglobalthroughtheintroductionofacommondossierframeworkpivottowardsmoreaffordablehealthcaresolutions.andtheharmonisationoftechnicalrequirements,asGenericdrugsaredefinedbytheWorldHealthwellastheimplementation,adoption,oradaptationofOrganization(WHO)aspharmaceuticalsusuallyintendedsaidframeworkandguidelinesbyNationalRegulatorytobeinterchangeablewithoriginatorbrandproducts,Agencies(NRAs),haveledtosignificantlystreamlinedmanufacturedwithoutalicencefromtheoriginatorregulatorypathwaysandquickenedmarketentry.manufacturer,andmarketedafterth...