美国《药品非临床质量管理规范》英文版.docx

美国《药品非临床质量管理规范》英文版.docx

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美国《药品非临床质量管理规范》英文版

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION

DEPARTMENTOFHEALTHANDHUMANSERVICES

SUBCHAPTERA--GENERAL

SubpartA--GeneralProvisions

Sec.58.1Scope.

（a）ThispartprescribesgoodlaboratorypracticesforconductingnonclinicallaboratorystudiesthatsupportorareintendedtosupportapplicationsforresearchormarketingpermitsforproductsregulatedbytheFoodandDrugAdministration,includingfoodandcoloradditives,animalfoodadditives,humanandanimaldrugs,medicaldevicesforhumanuse,biologicalproducts,andelectronicproducts.Compliancewiththispartisintendedtoassurethequalityandintegrityofthesafetydatafiledpursuanttosections406,408,409,502,503,505,506,510,512-516,518-520,721,and801oftheFederalFood,Drug,andCosmeticActandsections351and354-360FofthePublicHealthServiceAct.

（b）ReferencesinthisparttoregulatorysectionsoftheCodeofFederalRegulationsaretochapterIoftitle21,unlessotherwisenoted.

[43FR60013,Dec.22,1978,asamendedat52FR33779,Sept.4,1987;64FR399,Jan.5,1999]

Sec.58.3Definitions.

Asusedinthispart,thefollowingtermsshallhavethemeaningsspecified:

（a）ActmeanstheFederalFood,Drug,andCosmeticAct,asamended（secs.201-902,52Stat.1040etseq.,asamended（21U.S.C.321-392））.

（b）Testarticlemeansanyfoodadditive,coloradditive,drug,biologicalproduct,electronicproduct,medicaldeviceforhumanuse,oranyotherarticlesubjecttoregulationundertheactorundersections351and354-360FofthePublicHealthServiceAct.

（c）Controlarticlemeansanyfoodadditive,coloradditive,drug,biologicalproduct,electronicproduct,medicaldeviceforhumanuse,oranyarticleotherthanatestarticle,feed,orwaterthatisadministeredtothetestsysteminthecourseofanonclinicallaboratorystudyforthepurposeofestablishingabasisforcomparisonwiththetestarticle.

（d）Nonclinicallaboratorystudymeansinvivoorinvitroexperimentsinwhichtestarticlesarestudiedprospectivelyintestsystemsunderlaboratoryconditionstodeterminetheirsafety.Thetermdoesnotincludestudiesutilizinghumansubjectsorclinicalstudiesorfieldtrialsinanimals.Thetermdoesnotincludebasicexploratorystudiescarriedouttodeterminewhetheratestarticlehasanypotentialutilityortodeterminephysicalorchemicalcharacteristicsofatestarticle.

（e）Applicationforresearchormarketingpermitincludes:

（1）Acoloradditivepetition,describedinpart71.

（2）Afoodadditivepetition,describedinparts171and571.

（3）Dataandinformationregardingasubstancesubmittedaspartoftheproceduresforestablishingthatasubstanceisgenerallyrecognizedassafeforuse,whichuseresultsormayreasonablybeexpectedtoresult,directlyorindirectly,initsbecomingacomponentorotherwiseaffectingthecharacteristicsofanyfood,describedin170.35and570.35.

（4）Dataandinformationregardingafoodadditivesubmittedaspartoftheproceduresregardingfoodadditivespermittedtobeusedonaninterimbasispendingadditionalstudy,describedin180.1.

（5）Aninvestigationalnewdrugapplication,describedinpart312ofthischapter.

（6）Anewdrugapplication,describedinpart314.

（7）Dataandinformationregardinganover-the-counterdrugforhumanuse,submittedaspartoftheproceduresforclassifyingsuchdrugsasgenerallyrecognizedassafeandeffectiveandnotmisbranded,describedinpart330.

（8）Dataandinformationaboutasubstancesubmittedaspartoftheproceduresforestablishingatoleranceforunavoidablecontaminantsinfoodandfood-packagingmaterials,describedinparts109and509.

（9）[Reserved]

（10）ANoticeofClaimedInvestigationalExemptionforaNewAnimalDrug,describedinpart511.

（11）Anewanimaldrugapplication,describedinpart514.

（12）[Reserved]

（13）Anapplicationforabiologicslicense,describedinpart601ofthischapter.

（14）Anapplicationforaninvestigationaldeviceexemption,describedinpart812.

（15）AnApplicationforPremarketApprovalofaMedicalDevice,describedinsection515oftheact.

（16）AProductDevelopmentProtocolforaMedicalDevice,describedinsection515oftheact.

（17）Dataandinformationregardingamedicaldevicesubmittedaspartoftheproceduresforclassifyingsuchdevices,describedinpart860.

（18）Dataandinformationregardingamedicaldevicesubmittedaspartoftheproceduresforestablishing,amending,orrepealingaperformancestandardforsuchdevices,describedinpart861.

（19）Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforobtaininganexemptionfromnotificationofaradiationsafetydefectorfailureofcompliancewitharadiationsafetyperformancestandard,describedinsubpartDofpart1003.

（20）Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforestablishing,amending,orrepealingastandardforsuchproduct,describedinsection358ofthePublicHealthServiceAct.

（21）Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforobtainingavariancefromanyelectronicproductperformancestandardasdescribedin1010.4.

（22）Dataandinformationregardinganelectronicproductsubmittedaspartoftheproceduresforgranting,amending,orextendinganexemptionfromanyelectronicproductperformancestandard,asdescribedin1010.5.

（23）Apremarketnotificationforafoodcontactsubstance,describedinpart170,subpartD,ofthischapter.

（f）Sponsormeans:

（1）Apersonwhoinitiatesandsupports,byprovisionoffinancialorotherresources,anonclinicallaboratorystudy;

（2）ApersonwhosubmitsanonclinicalstudytotheFoodandDrugAdministrationinsupportofanapplicationforaresearchormarketingpermit;or

（3）Atestingfacility,ifitbothinitiatesandactuallyconductsthestudy.

（g）Testingfacilitymeansapersonwhoactuallyconductsanonclinicallaboratorystudy,i.e.,actuallyusesthetestarticleinatestsystem.Testingfacilityincludesanyestablishmentrequiredtoregisterundersection510oftheactthatconductsnonclinicallaboratorystudiesandanyconsultinglaboratorydescribedinsection704oftheactthatconductssuchstudies.Testingfacilityencompassesonlythoseoperationalunitsthatarebeingorhavebeenusedtoconductnonclinicallaboratorystudies.

（h）Personincludesanindividual,partnership,corporation,association,scientificoracademicestablishment,governmentagency,ororganizationalunitthereof,andanyotherlegalentity.

（i）Testsystemmeansanyanimal,plant,microorganism,orsubpartsthereoftowhichthetestorcontrolarticleisadministeredoraddedforstudy.Testsystemalsoincludesappropriategroupsorcomponentsofthesystemnottreatedwiththetestorcontrolarticles.

（j）Specimenmeansanymaterialderivedfromatestsystemforexaminationoranalysis.

（k）Rawdatameansanylaboratoryworksheets,records,memoranda,notes,orexactcopiesthereof,thataretheresultoforiginalobservationsandactivitiesofanonclinicallaboratorystudyandarenecessaryforthereconstructionandevaluationofthereportofthatstudy.Intheeventthatexacttranscriptsofrawdatahavebeenprepared（e.g.,tapeswhichhavebeentranscribedverbatim,dated,andverifiedaccuratebysignature）,theexactcopyorexacttranscriptmaybesubstitutedfortheoriginalsourceasrawdata.Rawdatamayincludephotographs,microfilmormicrofichecopies,computerprintouts,magneticmedia,includingdictatedobservations,andrecordeddatafromautomatedinstruments.

（l）Qualityassuranceunitmeansanypersonororganizationalelement,exceptthestudydirector,designatedbytestingfacilitymanagementtoperformthedutiesrelatingtoqualityassuranceofnonclinicallaboratorystudies.

（m）Studydirectormeanstheindividualresponsiblefortheoverallconductofanonclinicallaboratorystudy.

（n）Batchmeansaspecificquantityorlotofatestorcontrolarticlethathasbeencharacterizedaccordingto58.105（a）.

（o）Studyinitiationdatemeansthedatetheprotocolissignedbythestudydirector.

（p）Studycompletiondatemeansthedatethefinalreportissignedbythestudydirector.

[43FR60013,Dec.22,1978,asamendedat52FR33779,Sept.4,1987;54FR9039,Mar.3,1989;64FR56448,Oct.20,1999;67FR35729,May21,2002]

Sec.58.10Applicabilitytostudiesperformedundergrantsandcontracts.

WhenasponsorconductinganonclinicallaboratorystudyintendedtobesubmittedtoorreviewedbytheFoodandDrugAdministrationutilizestheservicesofaconsultinglaboratory,contractor,orgranteetoperformananalysisorotherservice,itshallnotifytheconsultinglaboratory,contractor,orgranteethattheserviceispartofanonclinicallaboratorystudythatmustbeconductedincompliancewiththeprovisionsofthispart.

Sec.58.15Inspectionofatestingfacility.

（a）AtestingfacilityshallpermitanauthorizedemployeeoftheFoodandDrugAdministration,atreasonabletimesandinareasonablemanner,toinspectthefacilityandtoinspect（andinthecaseofrecordsalsotocopy）allrecordsandspecimensrequiredtobemaintainedregardingstudieswithinthescopeofthispart.Therecordsinspectionandcopyingrequirementsshallnotapplytoqualityassuranceunitrecordsoffindingsandproblems,ortoactionsrecommendedandtaken.

（b）TheFoodandDrugAdministrationwillnotconsideranonclinicallaboratorystudyinsupportofanapplicationforaresearchormarketingpermitifthetestingfacilityrefusestopermitinspection.Thedeterminationthatanonclinicallaboratorystudywillnotbeconsideredinsuppo