中國與美國及歐盟獸用生物制品注冊管理的比較分析.pdf

1、Y77472G分類號南級絮目差≮犬等學(xué)位論文單位代碼：10019學(xué)號：26008中國與美國及歐盟獸用生物制品注冊管理的比較分析ComparisonofAdministrationofVeterinaryBiologicalProductRegistrationBetweenChinaandUSA，EU指導(dǎo)教師：拯這查熬援申請學(xué)位類別：盞醫(yī)亟專業(yè)名稱：亟隨盞醫(yī)：研究方向：盞醫(yī)藥亟筐理所在學(xué)院：動物醫(yī)堂瞳二00四年十二月AbstraetNo

2、wadays，mostcountriespracticetheadministrativesystemofregistrationapprovalforveterinarybiologicalproductsintheworldHowevertheadministrativesystemandregistrationrequirementsvaryamongthecountriesInthisstudytheChinesesystemw

3、ascomparedwiththeAmericanandtheEuropeanUnionsystemsBesidesthebriefcomparisonontheadministrativeinstitutionsandlawfoundationofdifferentcountrieswasundertaken，theshortageoftheChineseregistrationadministrationofveterinarybi

4、ologicalproductsandtechnicalrequirementswereemphasizedThemainconclusionsweredrawnasfollows：1TheregistrationregulationsassociatedwithregistrationadministrationofveterinarybiologicalproductswerenotestablishedcompletelyinCh

5、ina，EspeciallytherewasnotanytechnicalguidelineThereforethenotarizationandconsistencyoftheevaluationandtheauthenticityandreliabilitywerenotensured2，InUnitedStatesofAmericaandEuropeanUnion，onlyonespecialpersonwasresponsibl

6、eforaproductregistrationWhereas，anEvaluationCommitteewasinchargeofaveterinarybiologicalproductevaluationbywayofmeetinganddiscussingtogetherinChinaItisobviousthatitisoflowerefficiencyinChinaanddifficultforustokeeptegistra

7、tiondossiersecret3InChinathefourstagesincludinglaboratorytest，fieldtesttrialproductionandareatestwerenecessaryfordevelopinganewveterinarybiologicalproductItwasnotappropriateforcontrollingthepotentialriskWhiletherewereonl

8、ytwostages，namelylaboratorytestandfieldtestinUnitedStatesofAmericaandEuropeanUnion，whichwasusefulforreducingtheriskmentionedabove4InChinatheregulationforsubmittingsafetyefficacyanddurationofimmunitytestreportsofthreetofi

9、velorsofproductswasunreasonable，InUnitedStatesofAmericaandEuropeanUniononelotofproductandmoreanimalswereusedforsafetyefficacyanddurationofimmunitytest，F(xiàn)rompointsofviewmentionedaboveitwasshownthatthereweresomeshortcomings

10、inadministrationsystemofregistrationapprovalforveterinarybiologicalproductsinChinaSomesuggestionsregardingtheadministrationsystemofregistrationapprovalweregivenasfollowsFirstlymakingsomeregistrationregulationsandtechnica

11、lrequirementstobeperfective；Secondlysettingupasystemwithonespecialpersontoberesponsibleforevaluatingaveterinarybiologicalproduct；Thirdlydividingthedevelopmentofaveterinarybiologicalproductsintotwophases：laboratorytestand

12、fieldtrial；FourthlyabolishingtherequirementforusingmorethanonelotofproducttocarryoutthelaboratorysafetyefficacyanddurationofimmunitytestsThesesuggestionsprovidereferencesforrevisingtheChineseregistrationregulationandtech

13、niquerequirements，showingimportanttheoreticandrealizedsignificanceforharmonizeouradministrationsystemofregistrationapprovalwiththoseofothercountriesintheworldKeyword：Veterinarybiologicalproductregistration，administration