药品注册管理办法英文版

ProvisionsforDrugRegistration(SFDAOrderNo.28)ProvisionsforDrugRegistrationChapterIGeneralProvisionsArticle1TheProvisionsareformulatedforthepurposesofensuringthesafety,efficacyandqualityofdrugsandregulatingdrugregistrationinaccordancewiththeDrugAdministrationLawofthePeople'sRepublicofChina(hereinafterreferredtoastheDrugAdministrationLaw),AdministrativePermissionLawofthePeople'sRepublicofChina(hereinafterreferredtoasAdministrativePermissionLaw)andtheRegulationsforImplementationoftheDrugAdministrationLawofthePeople'sRepublicofChina(hereinafterreferredtoastheRegulationsforImplementationoftheDrugAdministrationLaw).Article2TheProvisionsapplytotheapplicationsfordrugclinicaltrial,drugproductionorimport,andconductingdrugapproval,relevanttestingfordrugregistration,orregulationthereof,withintheterritoryofthePeople'sRepublicofChina.Article3DrugregistrationreferstotheprocessofreviewandapprovalonwhichtheStateFoodandDrugAdministration,inaccordancewiththeofficialprocedures,evaluatesthesafety,efficacyandqualityofthedrugsappliedformarketing,anddecideswhetherornottoapprovesuchanapplication.Article4TheStateencouragestheresearchanddevelopmentofnewdrugsandadoptsthespecialreviewandapprovalwithrespecttoinnovativedrugs,newdrugsforseriousandlife-threateningdiseasesandtoaddressunmetmedicalneedsanddrugs.Article5TheStateFoodandDrugAdministrationisinchargeofdrugregistrationnationwide,andresponsibleforreviewingandapprovingtheclinicaltrial,productionandimportationofdrugs.Article6Thedrugregistrationshallfollowtheprinciplesofopenness,fairnessandjustice.TheStateFoodandDrugAdministrationadoptsthesystemofcollectiveresponsibilityofthechiefreviewers,thesystemofpublicizingandchallengingrelevantpersons,andthesystemofresponsibilitytracing,withsocialsupervisioninsuchproceduresasacceptance,inspection,reviewandapprovalandsending.Article7Intheprocessofdrugregistration,thedrugregulatorydepartmentshallmakeknowntothegeneralpublic,andholdhearingson,thematterswhichitdeemsofvitalimportanceandinvolvingpublicinterestsforthegrantingofpermission.Priortomakingthedecisionofadministrativelicensingthathasadirectbearingonthevitalinterestbetweentheapplicantandtheotherparty,thedrugregulatorydepartmentshallinformtheapplicantandtheinterestedpartyoftheirrightsofrequestingforhearings,makingstatementsandargues.Article8Thedrugregulatorydepartmentshallprovidetheapplicantwithaccesstoinformationonthestatusoftheacceptance,examination,inspection,reviewandapprovalofdrugregistrationapplicationandthefinalresolution.Thedrugregulatorydepartmentshallpublicizethefollowinginformationonitsofficialwebsitesorattheofficialpremisesforacceptingapplications:(1)theitems,procedures,feesandtheirbasis,andtimelinesofthedrugregistration,indexofallthedataneededtobesubmittedandmodeltextoftheapplicationform;(2)thenamelistandotherrelevantinformationonthepersonsinvolvedintheacceptance,examination,inspection,reviewandapprovalofdrugregistration;and(3)generalinformationaboutcategoriesofapproveddrugs,etc.Article9Thedrugregulatorydepartment,relevantinstitutionsandpersonsinvolvedinthedrugregistrationhaveanobligationtokeepthetechnicalsecretsandtrialdatasubmittedbytheapplicantconfidential.ChapterIIApplicationforDrugRegistrationArticle10Anapplicantfordrugregistration(hereinafterreferredtoasapplicant)referstotheinstitutionthatsubmitsadrugregistrationapplicationandassumescorrespondinglegalliability.AdomesticapplicantshallbeaninstitutionlegallyregisteredwithintheterritoryofPeople'sRepublicofChinathatindependentlyassumescivilliabilityandanoverseasapplicantshallbealegaloverseasdrugmanufacturer.Whereanoverseasapplicantappliesforimportdrugregistration,itshallbedonebyitsbranchorentrustedagencywithintheterritoryofPeople'sRepublicofChina.Thepersonswhohandletheapplicationfordrugregistrationshallhaveprofessionalknowledgeandbefamiliarwiththelawsandregulationson,andthetechnicalrequirementsfor,drugregistration.Article11Drugregistrationapplicationsincludeapplicationsfornewdrugs,genericdrugs,importdrugsandtheirsupplementaryapplicationsaswellasre-registrationapplications.Applicationsofdomesticapplicantsshallbehandledaccordingtotheproceduresandrequirementsfornewdrugsorgenericdrugs,whereasapplicationsofoverseasapplicantsshallbehandledaccordingtothoseforimportdrugs.Article12ApplicationfornewdrugsreferstoapplicationforregistrationofdrugsthathavenotbeenmarketedwithintheterritoryofPeople'sRepublicofChina.Applicationforchangingdosageformorrouteofadministration,orclaiminganewindicationformarketeddrugs,shallbesubmittedastheprocessofnewdrugapplication.ApplicationforgenericdrugsreferstoregistrationapplicationforproducingthedrugshavingexistingnationaldrugstandardwhichisapprovedtobemarketedbytheStateFoodandDrugAdministration,whereastheapplicationforbiologicalproductsshallbesubmittedastheprocessofnewdrugapplication.ApplicationforimportdrugsreferstoregistrationapplicationfordrugsmanufacturedabroadtobemarketedwithintheterritoryofthePeople'sRepublicofChina.Supplementaryapplicationreferstoapplicationforvariation,addition,orcancellationoftheitemsorco