药品注册管理办法 in English

-1-DRUGREGISTRATIONREGULATIONMay1,2005-Effective(TranslationbyRDPAC,forMemberuseonly)Chapter1:GeneralPrinciples.................................................................................................................1Chapter2:ApplicationforDrugRegistration.................................................................................2Chapter3:Pre-clinicalLaboratoryStudyofDrugs......................................................................3Chapter4:ClinicalStudyofDrugs......................................................................................................5Chapter5:ApplicationandApprovalofNewDrugs..................................................................9Chapter6:ApplicationandApprovalofDrugsAlreadywithNationalStandards........14Chapter7:ApplicationandApprovalforImportDrugs..........................................................15Chapter8:ApplicationandApprovalforOTCDrugs..............................................................18Chapter9:SupplementalApplicationforDrugRegistration..................................................19Chapter10:Re-registrationofDrugs...............................................................................................20Chapter11:AdministrationofDrugInspectionforRegistration........................................21Chapter12:AdministrationofDrugRegistrationStandards.................................................22StandardSubstance.....................................................................................................................................24Chapter13:DrugRegistrationPrescribedTimeline...................................................................25Chapter14:Reconsideration.................................................................................................................28Chapter15:LegalLiability.....................................................................................................................28Chapter16:Miscellaneous......................................................................................................................29Annex1:RegistrationCategoriesandApplicationInformationRequirementsofTCMandNaturalDrugs......................................................................................................................................31Annex2:RegistrationCategoriesandApplicationInformationRequirementsofChemicalDrugs...........................................................................................................................................32Annex3:RegistrationCategoriesandApplicationInformationItemsRequirementsofBiologicalProducts.....................................................................................................................................48Annex4:RegistrationItemsandApplicationInformationRequirementsofSupplementalApplicationofDrugRegistration...........................................................................68Annex5:ApplicationInformationItemsofDrugRe-Registration......................................79Chapter1:GeneralPrinciplesArticle1:ThisRegulationispromulgatedaccordingtotheDrugAdministrationLawofThePeople’sRepublicofChina(DrugAdministrationLaw)andtheImplementingRegulationoftheDrugAdministrationLawofThePeople’sRepublicofChina(ImplementingRegulation)toensurethesafety,efficacyandqualitycontrolofdrugsandstandardizedrugregistration.Article2:ThisRegulationshallapplytoalldrugresearchandclinicalstudies,applicationforclinicalstudy,drugproductionorimportation,aswellastherelateddrugregistrationinspectionanddrugadministrationinThePeople’sRepublicofChina(PRC).Article3:DrugregistrationmeansthelegalprocessbywhichadecisionismadebySFDA,uponapplicationofregistrationapplicant,toeitherapproveornotapprovethe-2-conductingofadrugclinicaltrial,productionorimportationofadrugtobemarketed,basedonasystematicevaluationofthesafety,efficacyandqualitycontrolofthedrug.Article4:TheStateshallencourageresearchanddevelopmentofnewdrugsandexercisefasttrackapprovalforinnovativenewdrugs,thosefordifficulttotreatandlifethreateningdiseases,anddrugsneededforemergencyuse.Article5:TheStateFoodandDrugAdministration(SFDA)isthecompetentnationalauthorityfordrugregistration,responsibleforthereviewandapprovalofclinicalstudies,productionandimportationofdrugs.ProvincialDrugAuthorities(PDA)shallbeauthorizedbySFDAtoexaminethecompleteness,standardizationandauthenticityofanapplicationdossier,andorganizeinspectionofthepilotmanufactureddrugs.Article6:Adrugregistrationapplicant(applicant)meansaninstitutionwhichmakesapplicationforandassumescorrespondingliabilityfordrugregistration,andholdsthedrugapprovalcertificateafterapprovalhasbeenobtained.AlocalapplicantshallbealegallyregisteredinstitutioninChinaandbecompetenttoindependentlyassumelegalliability.AforeignapplicantshallbealegallyestablishedpharmaceuticalcompanyoutsideofChina.Inmakingapplicationforanimportdrugregistration,theforeignapplicantshalluseitsofficeinChina,orauthorizeanagentinChinatohandletheapplication.Thepe