仿制藥項目英文課件

EnglishcoursewareforgenericdrugprojectsCATALOGUE目錄IntroductionOverviewofGeneralDrugProjectsResearchandproductionofgenericdrugsThemarketandpolicyenvironmentofgenericdrugsFutureprospectsofgenericdrugs01IntroductionGeneraldrugsarecopiesofbrandnamedrugsthatareapprovedbytheFDAandmeettherequirementsforsafety,efficacy,andqualityTheyaremarketedaftertheexpirationofthepatentforthebrandnamedrugandarecurrentlylessexpensivethanthebrandnamedrugDefinitionofgenericdrugsGenericdrugscansignificantlyreducehealthcarecostsbypromotinganaffordablealternativetobrandnamedrugsTheyalsohelpincreaseaccesstoessentialdrugsforpatientswhocannotafterbrandnamedrugsGeneraldrugsareanimportantpartoftheUSgovernment'sefforttocontainhealthcostsandprovideaccesstoqualityhealthforallAmericansTheimportanceofgenericdrugsThefirstgeneralbugwasapprovedbytheFDAin1938Inthe1970s,theDegreepassedtheDrugPriceCompetitionAct,whichallowedgenericdrugstobemarketedaftertheexpirationofapatentforabrandnamedrugSincethen,theuseofgenericdrugshasincreasedsignificantly,accountingformorethan90%ofallsubscriptionsfilledintheUStodayThehistoryanddevelopmentofgenericdrugs02OverviewofGeneralDrugProjectsGeneraldrugprojectsareprojectsthataimtodevelopandproducegenericdrugs,whicharedrugsthatarebioequivalenttobrandeddrugsandcanbeusedassubtitlesforbrandeddrugsGenericdrugprojectssharethefollowingcharacteristics:lowcost,highefficiency,andtheabilitytoprovidedrugstopatientswhoneedthemquicklyandcheaplyDefinitionandcharacteristicsofgeneraldrugprojectsTheprocessofgenericdrugprojectstypicallyincludesthefollowingsteps:targetselection,preclinicalresearch,clinicalresearch,production,andmarketingEachsteprequiresspecificexpertiseandresourcestoensurethesuccessoftheprojectTheprocessofgeneraldrugprojectsThemainchallengesforgeneraldrugprojectsincludeensuringthequalityofthedrugs,observingregulatoryapproval,andmarketingthedrugseffectivelyToaddressthesechallenges,genericdrugcompaniescantakethefollowingmeasures:investinresearchanddevelopmenttoimproveproductquality,workcloselywithregulatorstoensurecompliance,anddevelopmarketingstrategiesthattargetspecificpatientgroupsChallengesandsolutionsforgeneraldrugprojects03ResearchandproductionofgenericdrugsDrugtargetidentificationIdentifyingthetargetofthedrug,whichcanbeaproteinoragene,isacriticalstepintheresearchanddevelopmentstageThisstepinvolvesunderstandingthemechanismofthediseaseandhowthedrugcaninterferewithitPreclinicalstudiesPreclinicalstudiesareconductedtoevaluatethesafety,efficacy,pharmacology,andpharmacodynamicsofthedrugcandidateinanimalsThesestudiesprovideimportantinformationforfurtherclinicaldevelopmentPatentapplicationGeneraldrugdevelopersneedtoensurethattheirproductdoesnotinvolveanypatentsTherefore,theyconductpatentsearchesandmayneedtoapplyfortheirownpatentstoprotecttheirintellectualpropertyrightsTheresearchanddevelopmentstageofgenericdrugsTheproductionstageofgenericdrugsManufacturingprocess:ThemanufacturingprocessofgenericdrugsmustbeabletoproducedrugsthatarebioequivalenttotheinnovatorproductThismeansthatthegenericdrugmusthavethesameactiveingredient,thesamedoseform,andbeproducedusingthesamemanufacturingprocessastheinnovatorproductQualitycontrol:QualitycontrolisessentialtoensurethatthegeneraldrugmeetstherequiredstandardsThisincludestestingtheactiveingredient,checkingthemanufacturingprocess,andconductingstabilityteststoensurethatthedrugisstableforthedurationofitsshelflifeLabelingandpackaging:ThelabelingandpackagingofgenericdrugsmustcomplywithregulationsandbeidenticaltotheinnovatorproductexceptionforminordifferencesallowedbylawThisincludesthelabeling,leaks,andboxesthatcomewiththedrugRegulatoryagencies:RegulatoryagenciessuchastheFoodandDrugAdministration(FDA)intheUnitedStatesandtheEuropeanMedicineAgency(EMA)inEuropeplayaclinicalroleinensuringthequalityofgeneraldrugsTheseagenciesconductrigorousinspectionstoensurethatgenericbugsmeettheirqualitystandardsQualitycontrolofgenericdrugsBatchtestingEachbatchofgenericdrugsmustbetestedtoensurethatitmeetstherequiredqualitystandardsThisincludestestingforimpacts,stability,potential,andotherrelatedparametersPostapprovalmonitoringAfteragenericbugisapproved,itsmanufacturersmustcontinuetomonitoritsqualityandsafetyThisincludesconductingpostapprovalinspections,audits,andadverseeventreportingtoensurethatanyissuesarepromptlyaddressedQualitycontrolofgenericdrugs04ThemarketandpolicyenvironmentofgenericdrugsVSGenericdrugsareinhighdemandduetotheircosteffectivenessandaccessibilityConsumersareincreasinglyseekingoutgeneralalternativestoexpensebrandeddrugsMarketsupplyWiththeexpirationofpatentsonmanybrandeddrugs,genericdrugmanufacturershavehadanopportunitytoenterthemarketandprovidelowcostalternativesMarketdemandMarketdemandandsupplyofgenericdrugsFDAregulationsTheUSFoodandDrugAdministration(FDA)hasimplementedpoliciestoresourcegenericdrugdevelopmentandmarketcompetitionTheseincludemeasurestostreamlinetheapprovalprocessforgenericdrugs要點一要點二InternationaltradeagreementsTradeagreementsbetweencountriescanaffectthemarketforgenericdrugsForexample,someagreementsmayrequirecountriestorecognizethepatientstatusofdrugs,sorestrictingthesaleofgeneralversionsThepolicyenvironmentofgenericdrugsQualitystandardsGenericdrugsmustmeetthesamequalitystandardsasbrandeddrugs,includingpurity,potential,andstabilityFDAinspectionsmanufacturingfacilitiestoensurecompliancewiththesestandardsBioequivalencetestingGenericdrugsmustbebioequivalenttotheirbrandedcounterparts,meaningtheymusthavethesamethermaleffectinthebodyBioequitytestingisconductedtodemonstratethisequityRegulationsandstandardsforgeneraldrugs05FutureprospectsofgenericdrugsIncreasinginvestmentinresearchanddevelopmentofgenericdrugs:Asthedemandforgenericdrugsrisks,moreandmorecompaniesareinvestinginresearchanddevelopmenttobringinnovativegenericdrugstothemarketAdvancementsinmanufacturingtechnology:Withthecontinuousadvancementofmanufacturingtechnology,genericdrugsarebecomingmoreeffectiveandcosteffectivetoproduce,enablingcompaniestoofferbetterqualityproductsatlowerpricesDevelopmentofnewdeliverysystems:Toimprovepatientcomplianceandconservation,companiesaredevelopingnewdeliverysystemsforgenericdrugs,suchasoraldisintegratingtablesandinfluencers010203Innovativedevelopmentofgenericdrugs010203ExpansioninemergingmarketsAsthemiddleclassinemergingmarketscontinuestogrow,thereisanincreasingdemandforaffordablehealth,drivingthegrowthofgenericdrugsinthesemarketsIncrementalregulatoryapprovalsToexpandtheirmarketreach,companiesareseekingregulatoryapprovalsinadditionalmarkets,andmanygenericdrugsarenowapprovedforsalesinEurope,Asia,andLatinAmericaCollaborationswithloc