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1、此篇内容可在国家食品药品监督管理局网站（英语版）下载药学英语交流群：163926581欢迎从事医药或翻译的人加入，大家共同学习交流ProvisionsforDrugRegistration(SFDAOrderNo.28)ProvisionsforDrugRegistrationChapterIGeneralProvisionsArticle1TheProvisionsareformulatedforthepurposesofensuringthesafety,efficacyandqualityofdrugsandregul
2、atingdrugregistrationinaccordancewiththeDrugAdministrationLawofthePeople'sRepublicofChina(hereinafterreferredtoastheDrugAdministrationLaw),AdministrativePermissionLawofthePeople'sRepublicofChina(hereinafterreferredtoasAdministrativePermissionLaw)andtheRegulationsfo
3、rImplementationoftheDrugAdministrationLawofthePeople'sRepublicofChina(hereinafterreferredtoastheRegulationsforImplementationoftheDrugAdministrationLaw).Article2TheProvisionsapplytotheapplicationsfordrugclinicaltrial,drugproductionorimport,andconductingdrugapproval,
4、relevanttestingfordrugregistration,orregulationthereof,withintheterritoryofthePeople'sRepublicofChina.Article3DrugregistrationreferstotheprocessofreviewandapprovalonwhichtheStateFoodandDrugAdministration,inaccordancewiththeofficialprocedures,evaluatesthesafety,effi
5、cacyandqualityofthedrugsappliedformarketing,anddecideswhetherornottoapprovesuchanapplication.Article4TheStateencouragestheresearchanddevelopmentofnewdrugsandadoptsthespecialreviewandapprovalwithrespecttoinnovativedrugs,newdrugsforseriousandlife-threateningdiseasesa
6、ndtoaddressunmetmedicalneedsanddrugs.Article5TheStateFoodandDrugAdministrationisinchargeofdrugregistrationnationwide,andresponsibleforreviewingandapprovingtheclinicaltrial,productionandimportationofdrugs.Article6Thedrugregistrationshallfollowtheprinciplesofopenness
7、,fairnessandjustice.TheStateFoodandDrugAdministrationadoptsthesystemofcollectiveresponsibilityofthechiefreviewers,thesystemofpublicizingandchallengingrelevantpersons,andthesystemofresponsibilitytracing,withsocialsupervisioninsuchproceduresasacceptance,inspection,re
8、viewandapprovalandsending.Article7Intheprocessofdrugregistration,thedrugregulatorydepartmentshallmakeknowntothegeneralpublic,andholdhearingson,th
