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1、DRUGREGISTRATIONREGULATION(SFDAOrder28)(TranslationbyRDPAC,forMemberuseonly)DrugRegistrationRegulationwasapprovedonJune18,2007bySFDAexecutivemeetingandisherebypublished,whichbecomeeffectivefromOctober1,2007.SFDACommissionerShaoMinliJuly10,2007DRUGREGIST
2、RATIONREGULATIONChapter1:GeneralPrinciplesArticle1:ThisRegulationispromulgatedaccordingtotheDrugAdministrationLawofThePeople’sRepublicofChina(DrugAdministrationLaw),AdministrativeLicensingLawofThePeople’sRepublicofChina(AdministrativeLicensingLaw),andth
3、eImplementingRegulationoftheDrugAdministrationLawofThePeople’sRepublicofChina(ImplementingRegulation)toensurethesafety,efficacyandqualitycontrolofdrugsandstandardizedrugregistration.Article2:ThisRegulationshallapplytoalldrugresearchandclinicalstudies,ap
4、plicationforclinicalstudy,drugproductionand/orimportation,aswellasthedrugapprovalreview,registrationinspectionanddrugadministrationinThePeople’sRepublicofChina(PRC).Article3:DrugregistrationmeansthelegalprocessbywhichadecisionismadebySFDA,uponapplicatio
5、nofregistrationapplicant,toeitherapproveornotapprovetheconductingofadrugclinicaltrial,productionorimportationofadrugtobemarketed,basedonasystematicevaluationofthesafety,efficacyandquality-55-controlofthedrug.Article4:TheStateshallencourageresearchanddev
6、elopmentofnewdrugsandexercisetheapprovalviaaspecialprocessofinnovativenewdrugs,thosefordifficulttotreatandlifethreateningdiseases.Article5:TheStateFoodandDrugAdministration(SFDA)isthecompetentnationalauthorityfordrugregistration,responsibleforthereviewa
7、ndapprovalofclinicalstudies,productionandimportationofdrugs.Article6:Drugregistrationshouldfollowtheprinciplesofopennessequality,fairness,andfortheconvenienceofthepublics.Duringdrugregistration,SFDAshallapplythesystemsofjointresponsibilityofthepresiding
8、reviewer,publicdisclosureandrescuingoftherelatedstaff,responsibilityinvestigationforanywrongdoing,inordertoadministerthestepsfromacceptance,inspection,review,approval,throughdelivery,andsubjecttomonitoringbythepublics.Article7:Du
