药品注册管理办法(英文版)--28号令.doc

药品注册管理办法(英文版)--28号令.doc

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ProvisionsforDrugRegistration

（SFDAOrderNo.28）

ProvisionsforDrugRegistration

ChapterI

GeneralProvisions

Article1TheProvisionsareformulatedforthepurposesofensuringthesafety,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.

ChapterII

ApplicationforDrugRegistration

Article10Anapplicantfordrugregistration（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,orcancellationoftheitemsorcontentsapprovedintheoriginalapplicationfornewdrug,genericdrugorimportdrug.

Re-registrationapplicationreferstoapplicationforcontinuedproductionorimportationofadrugaftertheexpirationofthevalidtermofthedrugapprovaldocument.

Article13Theapplicantshallprovidesufficientandreliableresearchdatatoprovethesafety,efficacyandqualityofthedrug,andbeliablefortheauthenticityofallthedossierssubmitted.

Article14Thecitedliteratureofthedossierofdrugregistrationshallindicatethetitleofworksorthename,volumenumber,issueandpageofthejournal.Wherethecitedreferencesarenotpublished,anauthor'spermissionshallbeprovided.Forforeignliteratures,Chinesetranslationshallbeprovidedasrequired.

Article15TheStateFoodandDrugAdministrationshallobeythedevelopmentplanandpoliciesonthepharmaceuticalindustryconstitutedbytheState,andmayconductassessmenttothemarketvalueofdrugs.

Article16Intheprocessofdrugregistration,thedrugregulatorydepartmentshallconducton-siteinspectionandcausalinspectiontothenon-clinicalstudiesandclinicaltrials,aswellasproductionsiteinspectionforthepre-marketingapprovaltoconfirmtheauthenticity,precisionandintegrityofthedossiersubmitted.

Article17Wheretwoormoreinstitutionsjointlyapplyfordrugs,theapplicationshallbesubmittedtothedrugregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernment,inwhichthedrugmanufacturerislocated;wheretheapplicantsarealldrugmanufacturers,theapplicationshallbesubmittedtothedrugregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernment,inwhichthemanufacturerofpharmaceuticalpreparationsislocated;wherenoneoftheapplicantsisadrugmanufacturer,theapplicationshallbesubmittedtothedrugregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernment,inwhichthesiteforpilotproductionofdrugsamplesislocated.

Article18AnapplicantshallprovidetheinformationonpatentanditsownershipoftheapplicantorotherpartiesinChina,inrespectofthedrugappliedforregistration,itsformula,manufacturingprocessesand/oruses,etc.WhereanotherpartyownsthepatentinChina,theapplicantshallprovideastatementofnon-infringement.Thedrugregulatorydepartmentshallpublishtheinformationorthestatementsubmittedbytheapplicantonitsofficialwebsite.

Whereapatentdisputeoccursintheprocessofdrugregistration,itshallbesettledinaccordancewithrelevantlawsandregulationsonpatent.

Article19ForadrugpatentedinChina,applicantsotherthanthepatenteemaysubmittheapplicationforregistrationtwoyearspriortotheexpirydateofthepatent.TheStateFoodandDrugAdministrationshallreviewthedrugapplicationinaccordancewiththeProvisions,andaftertheexpirydateofthepatent,checkandissuethedrugapprovalnumber,ImportDrugLicenseoraPharmaceuticalProductLicenseiftheapplicationconformswiththeprovisions.

Article20InaccordancewiththeprovisionsinArticle35oftheRegulationsforImplementationoftheDrugAdministrationLaw,whereamanufacturerordistributorsubmitsundiscloseddrugexperimentalandotherdatawhichareindependentlyacquiredinordertoobtainapprovalforproductionormarketingofthedruginquestionwhichcontainsanynewchemicalentity,theStateFoodandDrugAdministrationshall,withinsixyearsfromtheapprovaldateofthedrug,rejectanyapplicationmadebyanyotherapplicantsbyusingtheundiscloseddataofthedruginquestionwithoutpermissionoftheoriginalapplicantwhohasobtainedthedrugapproval,unlessthedatasubmittedareindependentlyacquiredbytheapplicantsotherthantheoriginalone.

Article21Pre-clinicaldrugstudy