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1、药品非临床研究质量管理规范英文版来源：本站原创更新：2008-7-24医学英语论坛SDA:DrugGoodLaboratoryPractices(Transitional)SDARegulation;OrderNo.14;EffectiveDate:1999-11-01;RepealDate:2003-09-01(PromulgatedbyOrderNo.14oftheStateDrugAdministrationonOctober14,1999,effectiveasofNovember1,1999,andabolishedonSe
2、ptember1,2003)ChapterⅠ-GeneralProvisionsArticle1Theprovisionsareestablishedforimprovingthequalityofnon-clinicallaboratorystudiesonnewdrugs,forassuringthetruthfulness,integrityandreliabilityofexperimentaldata,andforensuringdrugsafetyforhumanusepursuanttothestipulationsof
3、theDrugControlLawofthePeople'sRepublicofChina.Article2Theprovisionsshallbeadaptedtonon-clinicallaboratorystudiesforapplicationsofdrugregistration.Allnon-clinicalresearchorganizationsshallfollowtheprovisions.Article3Thetermsusedintheprovisionsaredefinedasfollows:1.Non-cl
4、inicallaboratorystudymeansanytoxicityexperimentsperformedunderlaboratoryconditionstoevaluatethesafetyofnewdrugs,includingstudiesofsingledosetoxicity,repeateddosetoxicity,reproductiontoxicity,mutagenicaction,carcinogenecity,irritation,dependenceandothers.2.Non-clinicalre
5、searchorganizationmeansthefacilitywhichconductsnon-clinicallaboratorystudiesofnewdrugs,includingsafetyresearchcenters,safetyresearchinstitutes,researchlaboratoriesorteamsforsafetystudies,etc.3.Testsystemmeansanimals,plants,microorganismsorcellsusedtoconducttoxicitystudi
6、es.4.Qualityassuranceunitmeansanyunitinnon-clinicalresearchorganizationsthatisdesignedtoassurethatthestudyisincompliancewiththeprovisions.5.Studydirectormeansthepersonwhoisresponsiblefortheoverallconductionofacertainstudyproject.6.Testarticlemeansanydrugorsubstancetobed
7、evelopedintoadrugusedtoconductanon-clinicallaboratorystudy.7.Control/referencearticlemeansanydrugoranyotherproductusedinnon-clinicallaboratorystudiesforthepurposeofestablishingabasisforcomparisonwiththetestarticle.8.Rawdatameananymaterialsandoriginaldocumentsorrecordswh
8、ichrecordtheoriginalresearchobservations,includingworksheets,notes,photographs,microficheormicrofilmcopies,mic
