OpportunityandInfluenceforLocalizedDevelopmentPharmaceuticalR&DTrendsinChina21%4%33%32%31%35%21%43%201120145,877Applications7,829ApplicationsInnovatorsGenericsLabelchangesOthersFig1:R&Dpipelinegrowth(2011-2014)ChinaChemicalDrugsApplicationsStructureSource:CenterforDrugEvaluationatChinaFoodandDrugAdministrationAshiftinglandscape—keyimplicationsTheChinesegovernmenthasmadesignificantmulti-prongedinvestmentstogrowthelocalR&Dindustry.TheaggregateresultisincreasedlocalR&Doutput,amoreinnovativeR&Dpipeline(Fig1)andChina’sgrowingimportanceinsupportofglobalandregionalstudysubmissions.GreatfluxinR&DregulatoryreformLaunchinglocalclinicalstudiesforoverseasclinicalprogramshavetraditionallybeenchallengedbytwomainbarriersinChina:theChinaFoodandDrugAssociation’s(CFDA)requirementthatadrugberegisteredinaforeigncountryorinphaseIIorphaseIIIclinicaltrialsandalengthierprocessforINDandNDAregistrationthaninothermarkets.Altogether,thesebarrierscancauselocalproductlaunchestotakefivetoeightyears,discouraginginnovativeprogramsfromenteringChinabyerodinglargerrevenuesfrompatentprotection.ThoughthegovernmentisacceleratingR&Dregulatoryreform,largevolatilityhasbeenseenandisexpectedtocontinue.Forexample,in2014,theCFDAandR&DBasedPharmaceuticalAssociationCommittee(RDPAC)hadseveralexchangeswithseeminglyoppositeresults.DespitearecentannouncementfromtheCFDAaboutapilotreformpotentiallycuttingINDapprovaltimesforoncologydrugsfromone-twoyearsdownto60days,potentialimpactsonoverseasdevelopmentprogramsinChinaremainunknown,andmorediscussionsarestillrequiredtodefinethespecificreformagendaandtimeline.Furthermore,identifyingwhethercentralorlocalregulatoryagencieshavethecapacitytoimplementreformhasalwaysbeenachallenge,whichcouldincreasevolatilityinthenearterm.ThisfluxcanhavealargeimpactonMNCpharmaswantingtoimportinnovativeprogramstoChina.ThecompaniesmustchangetheircurrentglobalR&DmodelstomitigatetheefficiencyriskintroducedbyChina’slocalpolicyenvironment.Growingneedfor“MadeforChina”drugsAddressingunmetneedssp...
