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《2012 China Drug Review Annual Report》由會(huì)員上傳分享，免費(fèi)在線閱讀，更多相關(guān)內(nèi)容在學(xué)術(shù)論文-天天文庫。
1、2012ChinaDrugReviewAnnualReportCenterforDrugEvaluation(CDE),ChinaFoodandDrugAdministration(CFDA)Dateofrelease:February28,2013OnAugust31,2012,a60cmhighbronzestatuecalled"thesickchild"wasunveiledinStolberg,WestGermany.Ontheleftofthebronzestatueisagirlbornwithoutarm
2、sandwithdefectedlegsleaninginachairandtherightsideisanemptychair.Inthemiddleofthefoundation,thefollowingwordsarecarved:“Inmemoryofthedeadandsurvivedthalidomidevictims”.Thisthyearmarksthe50anniversaryofthalidomideincident.Itisthistragedythatonceshockedtheworld.Int
3、he1950s,aGermandrugmanufacturerintroducedthesedativeofthalidomide,whichbecamepopularinmanycountriesforitseffectivenessinalleviatingthesymptomsofmorningsicknessduringearlystagesofwomen’spregnancy.Meanwhile,amedicalofficer,namedFrancesOldhamKelseyattheUSFoodandDrug
4、Administration(FDA)wasreviewinginformationsubmittedbythisGermancompany.Becauseofherconcernoverthedata,thalidomide’sapprovalwaswithheldintheUnitedStates.Later,whencongenitalmissinglimbsofnewborninfants,i.e.thalidomidebabiesemergedfromEurope,Australia,CanadaandJapa
5、nwherethedrugwasused,itbecameclearthat,withthesupportofscientificevidence,theculpritofmissinglimbsinnewborninfantsisthalidomide.Bythen,therewerealmost10,000thalidomidebabiesbornaroundtheworld.Itisalsothistragedythathasdriventhereformeffortinimprovingscientificrev
6、iewandapprovalsysteminvariouscountriesofEuropeandtheUSsincethe1960s.China’sescapefromthetragedyismainlyduetorelativelyunderdevelopedinnovateddrugsectorandlackoftheconnectivityofpharmaceuticalindustrytotherestoftheworld.However,Chinahaditsownchallenges,mainlyaseri
7、ousshortageofdrugsasmostofdrugresearchanddevelopmentinChinafocusedongenericdrugsandthesupplyofdrugproductswaslimited.Theworldhasundergonegreattransformationoverthepasthalfacenturyandglobalizationofresearchanddevelopmentactivitiesandsupplyofdrugproductsisnowtherea
8、lity.Afterthetragedy,EuropeandtheUSintroducedstatelegislation,governmentregulationandestablishedacompletescience-baseddrugreviewsystem.After1949,Chinaestablish
