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1、ClinicalTrialsinKorea:WhyKorea?YoungJackLee,Ph.D.PresidentLSKGlobalPharmaServicesSeoul,Koreajacklee@lskglobal.comKoreaisnewtomoderndayclinicaltrials.BeforetheIND(InvestigationalNewDrug)systemwasintroducedin2002,theKoreaFoodandDrugAdministration(KFDA)requiredsafetya
2、ndefficacydataoftheinvestigationalproductforapprovingtheclinicaltrialapplication.Thisrequirementeffectivelyshutdowntrialsofinvestigationalnewproductsbefore2002.Drugtrialsthenweregenerallysmallwith30-90patients.MultinationalsponsorshadnoINDapprovalsbetween1993and200
3、0(seeFigure1).(AnINDtrialbefore2002inKoreaisamisnomer.Itwasasortofbridgingtrial,notanINDtrial.Butforconvenience,Iwillkeepabusingtheterm,IND.)KFDA,whichwasestablishedin1998,approvedfiveINDsformultinationalsponsorsin2000.Thenumberjumpedto17in2002.KFDAapproved148INDsf
4、ormultinationalsponsorsin2007.Thenumberwillbecloseto250thisyear,afiftyfoldincreasefromyear2000(seeFigure2).ThenumberofINDtrialsinKoreaisnowlargerthaninJapan.In1993,therewere160INDapprovalsinJapanand18inKorea.Sincethenthenumberofclinicaltrialshasbeensteadilyincreasi
5、nginKorea,whiledecreasinginJapan.In2002,therewere55INDapprovalsinKoreaand60inJapan.In2005,therewere185INDapprovalsinKoreawhile96inJapan(seeFigure1.),acompletereversalinashortperiod.Chinaisimportantforglobaldrugdevelopment.AccordingtothestatisticspresentedinApril200
6、8attheEastAsianPharmaceuticalRegulatorySymposium2008inTokyo,Japan,however,thenumberofINDapprovalsformultinationalsponsorsinKoreaislargerthaninChina:95in2005,108in2006,and148in2007inKoreawhile31in2005,61in2006,and53in2007inChina(seeFigure2and3).AlthoughChinaisexpect
7、edtocatch-up,atleastfornowKoreaismoreactiveinmultinationaltrialsthanChina.MultinationalsponsorsholdmoreKoreanINDsthandomesticsponsorssince2005.Thistrendwillcontinueandthegapwillgrowevenfurther.FortheJapanesedrugindustrywillincreaseclinicaltrialsinKoreaastheJapanese
8、authorityhasstartedacceptingKoreanclinicaltrialdataforJapaneseregistration.FurthermoretheJapanesegovernmentiscommittedtoregionalclinicaltrialsinv
