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首页 DRUG REGISTRATION REGULATION

DRUG REGISTRATION REGULATION.doc

DRUG REGISTRATION REGULATION

wolflee0625
2018-09-07 0人阅读 举报 0 0 暂无简介

简介:本文档为《DRUG REGISTRATION REGULATIONdoc》,可适用于医药卫生领域

DRUGREGISTRATIONREGULATIONChapter:GeneralPrinciples  Chapter:ApplicationforDrugRegistration  Chapter:PreclinicalLaboratoryStudyofDrugs  Chapter:ClinicalStudyofDrugs  Chapter:ApplicationandApprovalofNewDrugs  Chapter:ApplicationandApprovalofDrugsAlreadywithNationalStandards  Chapter:ApplicationandApprovalforImportDrugs  Chapter:ApplicationandApprovalforOTCDrugs  Chapter:SupplementalApplicationforDrugRegistration  Chapter:ReregistrationofDrugs  Chapter:AdministrationofDrugInspectionforRegistration  Chapter:AdministrationofDrugRegistrationStandards  StandardSubstance  Chapter:DrugRegistrationPrescribedTimeline  Chapter:Reconsideration  Chapter:LegalLiability  Chapter:Miscellaneous  Annex:RegistrationCategoriesandApplicationInformationRequirementsofTCMandNaturalDrugs  Annex:RegistrationCategoriesandApplicationInformationRequirementsofChemicalDrugs  Annex:RegistrationCategoriesandApplicationInformationItemsRequirementsofBiologicalProducts  Annex:RegistrationItemsandApplicationInformationRealityArticle:Duringtheinspectionofdrugstandards,inadditiontoinspectionofthesampleproducts,thedrugcontrolinstituteshallalsoissueaninspectionrecommendationregardingthedrugstandardsofthedrug,itemstobeinspectedandinspectionmethods,basedontheresearchdataofthedrug,thedrugstandardsofsimilarproductsdomesticandintheforeigncountriesaswellasnationalrequirementsBeforetheissuanceofinspectionrecommendations,thedrugcontrolinstituteshouldnotifytheapplicantifnecessaryIftheapplicantdisagreeswiththerecommendations,itshouldfileanobjectionwiththedrugcontrolinstitutewithindaysIfthedrugcontrolinstitutedisagreeswiththeapplicant'sobjection(explanation),itshallsubmittherecommendationtogetherwiththeapplicant'sexplanationtoSFDAwithcopiestotheapplicantandPDAwhichrequestedthedrugregistrationinspectionArticle:Inremakingadrug'sstandards,theapplicantshallnotauthorizethedrugcontrolinstitutewhichissuedtherecommendationstoconducttheresearchworkSimilarly,suchInstituteshallnotacceptsuchauthorizationChapter:AdministrationofDrugRegistrationStandardsSection:BasicRequirementsArticle:“Nationaldrugstandards”meansthetechnicalrequirementsforqualityparameters,inspectionmethodsandproductionprocessesofdrugsestablishedbytheStatetoensurethedrugquality,includingPharmacopoeiaofPeople’sRepublicofChina,drugregistrationstandardsandotherdrugstandardsissuedbySFDA“Drugregistrationstandards”meansthestandardsapprovedbySFDAforthespecificdrugoftheapplicantThepharmaceuticalproductionenterpriseshallcomplywiththedrugregistrationstandardsforthedrugArticle:Thedeterminationofitemsandinspectionmethodsfordrugregistrationstandardsshallmeettherequirementsofthetechnicalguidanceprinciples,relevantprinciplesandrulesforcompilingnationaldrugstandardsissuedbySFDAArticle:Anapplicantshall,conditionedonthestabilityofthequalityofrawmaterialsandproductionprocess,selectrepresentativesampleproductsforthestudyofstandardsSection:TransferofTemporaryDrugStandardstoFormalStandardsArticle:Afterapprovalofanewdrugforproduction,thequalitystandardsofthenewdrugwillbetemporarystandardsforatrialperiodofyearsIfaftertheapprovalofotherdrugs,thestabilityofproductionprocessesandqualitystandardsneedsfurtherreview,thequalitystandardsmaybeapprovedastemporarystandardsArticle:Forthedrugproducedwithtemporarydrugstandards,threemonthspriortotheexpirationoftemporarystandards,theenterpriseshallapplytotransferthetemporarystandardstoformalstandardsatthePDAwheretheenterpriseislocated,byfillingouttheDrugSupplementalApplicationFormandwiththesubmissionofqualityinspectioninformationduringthetrialperiodofthedrugstandardsandrecommendationsformodificationofthetemporarystandardsAfterapprovalofsupplementalapplicationofchangeofdrugstandards,ifthedrugstandardisstilltemporary,theenterpriseshouldapplytotransferthetemporarystandardstoformalstandardsthreemonthspriortotheexpirationoforiginaltemporarystandards,Article:PDAshallcompletethereviewoftheapplicationforthetransferoftemporarystandardstoformalstandardswithindaysofreceiptoftheapplication,andsubmittherecommendationsandrelevantdocumentstoSFDAArticle:SFDAshallorganizetheStatePharmacopoeiaCommissiontoexaminethetemporarystandardsofadrugTheStatePharmacopoeiaCommissionshall,basedontheuseofthedrugsduringtheperiodofthetemporarystandards,qualitystandardsoftherelevantproductsdomesticandoverseasandrelevantnationalrequirements,issuerecommendationsastowhetherinspectionofthetemporaryqualitystandardsisneededIfaninspectionisneeded,therelevantdrugcontrolinstituteshouldbeorganizedforinspectionandinspectionofthetemporarystandards,andotherinspectionworkArticle:Ifmorethanonepharmaceuticalproductionenterprisemanufacturesthesamedrug,druginspectionandinspectionofqualitystandardsfortransferoftemporaryqualitystandardstoformalstandardsshouldbeconductedbyNICPBPordrugcontrolinstitutedesignatedbySFDAArticle:Ifmorethanoneapplicanthasappliedtotransfertemporarystandardsofthesamedrugintoformalstandards,theproposedstandardsmaynotbelowerthanalreadyapproveddrugstandardsThesubsequentapplicantmayincludeadditionalinspectionitemsdependingonthecharacteristicsofitsdrugproductionprocessArticle:Whenthereisaneedforsupplementaltestorsupplementalinforation,uponreceiptofthenotificationofstardardinspectionorverification,applicantshall,withindaysofnotificationforqualitystandardinspection,completeandupdaterelevantsupplementalexperimentorinformationandsubmittothePDAArticle:SFDAshallcomprehensivelyexaminetheinformationsubmittedbyStatePharmacopoeiaCommission,andwhenSFDAconsidertherequirementsaremet,PublicationforNationalDrugStandardwillbeissuedWhenSFDAdoesnotconsidertherequirementsaremet,NotificationofApprovalOpinionwillbeissuedwithexplanationAtthesametime,SFDAwillcancelthetemporarystandardsandthedrugapprovalnumberapprovedaccordingtothetemporarystandardsArticle:Forthesamekindofdrugwithdifferenttrialperiodexpirationdates,thedrugwithtemporarystandardswhichwillfirstexpireshallbegintheprocessoftransferringtoformalstandardsForthedrugwithtemporarystandardswhichwillsubsequentlyexpire,theStatePharmacopoeiaCommissionshallnotifytheapplicanttomakeearlyapplicationtoPDAtotransfertoformalstandardsArticle:Ifanapplicantfailstoapplytotransfertoformalstandardsbeforetheexpirationofthetemporarystandardsaccordingtorelevantregulations,SFDAshallcancelthetemporarystandardsandthecorrespondingdrugapprovalnumberfordrugproductionDuringtheapplicationprocesstotransferofthetemporarystandardsintoformalstandards,thepharmaceuticalproductionenterpriseshallcontinuetomanufacturethedruginaccordancewiththerequirementsofthetemporarystandardsSection:EstablishmentandAdministrationofDrugStandardSubstanceArticle:Drugstandardsubstancemeansasubstancewithspecificvalues,usedinphysical,chemicalinspectionandbiologicalmethodsinspectionneededforthedrugqualitystandards,andusedtocalibrateequipments,toevaluatethemeasuringmethodsortoassaytheinspectiondrugsincludingstandards,controlproducts,rawmaterialcontrolproducts,andreferenceproductsArticle:NICPBPshallberesponsibleforstandardizationandadministrationofnationaldrugstandardsubstancesNICPBPmayorganizetherelevantprovincialdrugcontrolinstitute,researchinstitutionsorpharmaceuticalproductionenterpriseforcooperationinstandardizationandadministrationArticle:Duringtheapplicationprocessforproductionofanewdrug,theapplicantshallprovideNICPBPwithrawmaterialsneededforpreparationandstandardizationofthestandardsubstances,withtherelevantresearchinformationofthestandardsubstancesArticle:NICPBPshallberesponsibleforthecomprehensivetechnicalreviewofthestandardsubstanceregardingtheselectionofrawmaterials,productionmethods,standardizationmethods,standardizationresults,accuracyofassayvalues,tracingoforiginofvariousvalues,stabilityandconditionsforrepackagingandpackaging,toreachaconclusionastowhethertheycanbeusedasnationalstandardsubstancesChapter:DrugRegistrationPrescribedTimelineArticle:SFDAandPDAshallpubliclypublishintheofficialwebsiteandregisteringofficethecondition,procedure,durationandlistofallthedocumentofapplicationdossierneededfordrugregistration,aswellastemplateofapplicationformsArticle:SFDAandPDAshallissuenotificationinwritingofacceptanceandnonacceptanceofthedrugregistrationapplication,whichwillbechopped,datedandserverasfutureevidenceArticle:Theprescribedtimelinefordrugregistrationmeansthemaximumallowedtimefortherelevantreview,inspection,andprovidingofsupplementalinformationrelatedtodrugregistrationIfanyworkisfinishedwithinthetimelineofdrugregistration,thedossiershouldbeforwardedintothenextsteptimelyArticle:Uponreceiptofanapplication,PDAshall,withindays,notifytheapplicantinonenotificationallofsupplementalinformationandincompleteinformationrequiredbytheexamination,andintheeventoffailuretonotify,theapplicationwillbedeemedtoconsiderasacceptedApplicationshouldbeacceptedwithindaysforanapplicationwithcompleteinformationmeetingtheexaminationforform,orafterapplicantcompletealltherequiredsupplementalinformationArticle:Uponacceptanceoftheapplication,PDAshallbeginwithindays,andcompletewithindaystheonsiteinspection,takingofsampleproducts,notificationofthedrugcontrolinstituteforinspectionofsampleproductandsubmissionoftherecommendationandinspectionreporttogetherwithinformationsubmittedbytheapplicanttoSFDA,andatthesametime,notifytheapplicantoftheinspectionrecommendationsArticle:Adrugcontrolinstituteshall,withindaysofreceiptofthenotificationandsampleproducts,completetheinspectionandissuetheinspectionreportTheinspectionforspecialdrugsandvaccineproductsshallbecompletedwithindaysArticle:Ifinspectionofsampleproductsandverificationofdrugstandardsareneeded,drugcontrolinstitutesshallcompletesuchworkwithindaysAninspectionforspecialdrugsandvaccineproductsshallbecompletedwithindaysArticle:Forregistrationofimportdrug,DAshallexamineforformtheapplicationdossier,andiftherequirementsaremet,theapplicationwillbeacceptedSFDAshallbegintherelevantworkwithindays,andcompleteexaminationofapplicationinformationwithindays,andnotifyNICPBPtoconducttheinspectionSFDAshall,ifnecessary,organizeonsiteinspectionoftheresearchandproductioncondition,andtakesampleproductsWhenSFDAdoesnotconsidertherequirementsaremet,SFDAshallwithindaysnotifytheapplicantwithexplanationFailuretonotifytheapplicationshouldbedeemasacceptanceofapplicationArticle:NICPBPshall,withindaysuponreceiptoftheinformationandthesampleproduct,arrangeforadrugcontrolinstitutetoconducttheinspectionArticle:ThedrugcontrolinstituteresponsibleforinspectionofimportdrugshallcompletetheinspectionandsubmittoNICPBPwithindaysofreceiptoftheinformation,thesampleproductsandtherelatedstandardsubstancesArticle:NICPBPshallorganizetheexpertstoconductatechnicalreviewwithindaysofreceiptoftheinspectedimportdrugstandards,andconductareinspectionofspecificitemsbasedonthereviewrecommendation,ifnecessaryArticle:SFDAshalladministerthetechnicalreviewduringthedrugregistrationinaccordancewiththefollowingprescribedtimeline)  completeindaysforanewclinicalstudy,completeindaysifadrugmeetstherequirementsunderArticleofthisRegulation)  completeindaysforproductionofnewdrug,completeindaysifadrugmeetstherequirementsunderArticleofthisRegulationand,)  completeindaysforapplicationregistrationofadrugalreadywithnationalstandards)  CompleteindaysforsupplementalapplicationifatechnicalreviewisneededThisArticleshallalsoapplytothetechnicalreviewofimportdrugsArticle:Duringthetechnicalreview,SFDAshallissueonenotificationregardingsubmissionofallneededsupplementarymaterialsExceptforapplicationmeetingtherequirementofArticleofthisRegulation,theapplicantshallatonetimesubmitalltherequiredsupplementalmaterialswithinmonthsIftheapplicantfailstosubmitwithintheprescribedtimeSFDAshallreturntheapplicationArticle:IfanapplicantobjectstoprovidingthematerialsdescribedinthenotificationforsupplementarymaterialsbySFDA,theapplicantshallobjectwithintheprescribedtimeIfthereisstilldisagreement,theapplicantmaysubmitawrittenreporttoSFDA,explainingitsreasonsandprovidingtechnicalmaterialsandthescientificbasistosupportitsreasonsSFDAshallissueitsdecisionafterreviewArticle:Whenanapplicationisreturnedorwithdrawnbytheapplicant,iftheapplicantneedtoreapply,aftertheapplicantsupplementsandcompletesrelevantexperimentsandgatheringofinformation,theapplicationmayberesubmittedfollowingtheoriginalprocedureIfanapplicationmeetstheprovisionofthisregulationandthereisnootherdrugofthesamekindenterintomonitoringperiod,SFDAorPDAshouldaccepttheapplicationArticle:Uponreceiptofthesupplementalinformation,SFDAshallcompletethetechnicalreviewwithinonethirdoforiginalprescribedtime,foradrugmeetstherequirementsunderArticle,SFDAshallcompletethetechnicalreviewwithinonefourthoforiginalprescribedtimeArticle:SFDAshallcompletetheapprovalprocesswithindaysuponthecompletionoftechnicalreviewForasupplementaldrugapplicationthatneedsSFDAapproval,SFDAshallcompletetheapprovalprocesswithindaysWhenapprovalcannotbecompletedwithdays,anextensionofcanbegrantedbyapprovalfromthemanagement,andfurtherextensionexceedingdayswillneedapprovalsfromStateCouncilArticle:TheStatePharmacopoeiaCommissionshallcompletethereviewofthetransferoftemporarydrugstandardstoformalstandardswithindaysTheresponsibledrugcontrolinstituteshallcompletetheinspectionfordrugandqualitystandardswithindays,anddelivertheinspectionrecommendationsandinspectionreporttotheStatePharmacopoeiaCommissionForspecialdrugsandvaccineproducts,theinspectionfordrugandqualitystandardsshallbecompletedwithinnomorethandaysandforsamekindofdrugmanufacturedbymorethanonemanufacturer,shallbecompletedwithdaysArticle:Duringtheexaminationofdrugregistrationapplication,SFDAorPDAshouldpublicpubistheapprovalprocedureandapprovalresultForthosematterofsignificantinterest,theapplicantandrelatedpartymaysubmitwrittenopinionasstatementorfordefendingArticle:Whenmakingdecisionofthedrugregistrationapplicationfromlawfulauthority,SFDAandPDAshallissuenotificationinwritingofregistrationacceptanceorapprovalandregistrationnonacceptanceornonapproval,withexplanationofreminderthatapplicantislawfullyentitledtoapplyingforreconsideration,administrativereconsiderationorfilingadministrativelawsuitArticle:SFDAandPDAshallnotifyapplicantoftheentitlementtoapplyingforhearingDuringdrugregistration,foodanddrugadministrationconsiderapprovalasanissueofsignificantpublicinterest,theissuesshouldbepubliclyannouncedandhearingshouldbeheldArticle:Onceadecisionofdrugregistrationapprovalismade,SFDAshould,withindas,announceanddeliverthedecisionArticle:SFDAshouldperiodicallypubliclypublishoveritsofficialwebsitealistofdrugformularyofthedrugalreadyapprovedbySFDAtoprovidesaccessforpublicretrievalArticle:Inspecialsituations,ifthereisaneedtoextendthetimelimitfordrugregistrationinspectionortechnicalreview,theextensionshouldbesubmittedtoSFDAforapprovalArticle:IfoneoftheprovisionsofArticleofAdministrativePermittingLawsofPeople’sRepublicofChina(AdministrativePermittingLaws)occurs,SFDAshouldproceedwiththecancellationofrelevantdrugapprovaldocumentChapter:ReconsiderationArticle:Whenanapplicantobjecttothedecisionofnonapproval,beforeapplyingforadministrativereconsideration,andfilinganadministrativelawsuit,theapplicantmayapplyforreconsiderationwithSFDAwithindaysuponreceiptofrejectiondecisionfordrugregistrationbyfillingoutDrugSupplementalApplicationFormtogetherwithanexplanationanditsreasonsThescopeofreconsiderationshallonlybefororiginalapplicationitemsArticle:SFDAshallcompletethereviewandissueitsdecisionandnotifytheapplicantwithindaysuponreceiptoftheapplicationforreconsiderationIfSFDAmaintainsitsoriginalrejectiondecision,nofurtherreviewwillbegiventotheapplicationArticle:Whenthereisaneedfortechnicalreviewduringthereconsideration,SFDAshallorganizethetechnicalexpertstocompletethereviewwithintheoriginalprescribedtimeChapter:LegalLiabilityArticle:IfoneoftheprovisionsofArticleofAdministrativePermittingLawsoccurs,SFDAshouldproceedwiththecancellationofrelevantdrugapprovaldocument,basedontherequestoftherelatedpartyorfromitslawfulauthorityArticle:Ifanapplicantisfoundtohaveprovidedfraudulentdrugregistrationinformationandorsampleproductofthedrugsduringtheapplicationofclinicalstudy,SFDAshallnotapprovetheapplication,andwarntheapplicantNomorenewapplicationforclinicaltrailfromthesameapplicantwillbeacceptedforoneyearIftheapplicationhasalreadybeenapproved,theapprovalcertificateshallbecanceled,andafineofRMB,,shallbeimposedAnapplicationforthedrugwhichissignedbythisindividualorinstitutionshallnotbeacceptedforyearsAdatabaseoffraudulentconductbyapplicantsshallbemaintained,andmaybepublishedArticle:Ifanapplicantisfoundtohaveprovidedfraudulentdrugregistrationinformationandorsampleproductofthedrugsduringtheapplicationofdrugproductionorimportation,SFDAshallnotapprovetheapplication,andwarntheapplicantNomorenewapplicationforclinicaltrailfromthesameapplicantwillbeacceptedforoneyearIftheapplicationofproductionandorimportationofthedrugshasalreadybeenapproved,theapprovalcertificateshallbecanceled,andafineofRMB,,shallbeimposed,anapplicationforthedrugwhichissignedbythisindividualorinstitutionnotbeacceptedforyearsAdatabaseoffraudulentconductbyapplicantsshallbemaintained,andmaybepublishedArticle:Duringthedrugregistration,ifSFDAandorPDAanditsstaffarefoundtoviolatetheprovisionsofthisregulationwithoneofthefollowingoccurrences,provisionsofArticle,Article,Article,andArticleofAdministrativePermittingLawsshallapply:)  Didnotwanttoacceptadrugregulationthatmetthelawfulrequirement)  Didnotwanttopubliclypublishtheinformationitemsofdrugregistration)  Failuretofulfillobligationtonotifyapplicantduringtheprocessofacceptanceandapproval)  Failuretonotifytheapplicantinonenotificationofallthesupplementalinformationthatmustbesupplemented,wheninformationsubmittedbyapplicantisincompleteornotmeetingthestatutoryform)  Failuretoexplainthereasonsnottoacceptornottoapproval)  Approvalofanapplicationnotmeetingtherequirementofthisregulation,orapprovalmadebeyonditsauthority)  Decisiontonotapproveanapplicationmeetingtherequirementofthisregulation,orfailuretoapprovewithinthetimelimitsetoutinthisregulation)  Collectfeewithnoconsultation,orcollectfeewithoutreferencetothestatutoryregulation)  AskfororacceptvaluablesorotherinterestfromanypartyArticle:UponthecancellationofDrugManufacturingLicenseofadrugmanufacturer,theDrugApprovalNumberheldbythemanufacturershallsubsequentlybecomeandvoid,andshallbecancelledbySFDA,andthecancellationshouldbepublicannouncedArticle:IntheeventthatGLPorGCPrequirementswerenotcompliedwithduringthedrugregistration,sanctionsshallbeimposedaccordingtoArticleoftheDrugAdministrationLawArticle:Ifadrugcontrolinstituteissuesafraudulentinspectionreportduringperformanceofitslegaldutyfordruginspectionduringthedrugregistrationprocess,sanctionsshallbeimposedaccordingtoArticleoftheDrugAdministrationLawArticle:IfprovisionofArticlecallsforanexperimenttoberepeated,butanapplicantrefusestorepeattheexperimentaccordingtorelevantrequirements,theapplicantshallbewarned,andorderedtocorrectthesituationIftheapplicantrefusestomakecorrections,theapplicationentitlementshallbecanceledChapter:MiscellaneousArticle:FormatofDrugApprovalNumbershouldreadGuoyaozhunH(Z,S,J)digitofyeardigitofserialnumber,whereHdenotechemicaldrug,ZdenoteTCM,SdenotebiologicalproductsandJdenoteimportdrugFormatofImportDrugLicenseshouldreadH(Z,S)digitofyeardigitofserialnumber,andFormatofDrugProductLicenseshouldreadH(Z,S)Cdigitofyeardigitofserialnumber,whereHdenotechemicaldrug,ZdenoteTCM,andSdenotebiologicalproductsFortheregistrationcertificatenumberofrepackingoflargepackagefromexChina,BwilladdedastheprefixoftheoriginalcertificatenumberFormatofNewDrugCertificateshouldreadGuoyaozhengH(Z,S)digitofyeardigitofserialnumber,whereHdenotechemicaldrug,ZdenoteTCM,andSdenotebiologicalproductsArticle:InadditiontothisRegulation,theapplicationfornarcotics,psychotropic,medicalusetoxicdrugsandradioactivedrugsshallalsobeadministeredaccordingtootherrelevantnationalregulationsArticle:SFDAshallpromulgateseparateregulationfortheregistrationofTCMmaterial,TCMherbandimportTCMmaterialthatregulatedwithapprovalnumberSFDAshallpromulgateseparateregulationfortheregistrationofinvitrodiagnosisreagentthatregulatedwithdrugregulationArticle:ThisRegulationiseffectivedateofpublicationDrugRegistrationRegulation(temporary)promulgatedbySDA(SDAorder)onOctober,shallbeabolishedaccordingl
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