中药产业标准建设与政府政策支持研究

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华中科技大学硕士学位论文中药产业标准建设与政府政策支持研究姓名:周晶申请学位级别:硕士专业:行政管理指导教师:黄栋20061031I“”“”“”IIAbstractThedissertation,basedontheresearchofdirectionoftheChinesetraditionalmedicineindustryandthepoliciessupportedbythegovernment,presentstheobjectiveofpromotingtheconstructionofstandardsofChinesetraditionalmedicineindustryandincreasingthecompetitivenessoftheseindustries.Inthestudy,theauthorappliescomparativeanalysisandothermethods,anddiscussestheorientationofthedevelopmentofstandardsaccordingtothestudyofthecharacteristicsoftheChinesetraditionalmedicineindustry,focusingonthepredominanceofthegovernmentintheprocessthatleadtodeveloptheindustries.Correspondingly,theauthor,takingthecurrentroleplayedbygovernmentintheindustriesintoaccountaswell,provideshersuggestions.DiscussingthestatusofChinesetraditionalmedicineconstruction,thedissertationexpoundsthethreefactorsinit----thenetworkeffect,theprotectionofintellectualpropertyrightsandtechnologicalinnovationrate.Then,analyzingtheorientationofstandardsoftheindustriesimpactedonbythethreefactorswhichhavementionedabove,theauthoradvocatesthatthestandardsshouldbeformulatedbydrawnontheforeignstandardsforsomepartandworkedoutindependentlyfortheother.Intheconstructionofstandards,itisnecessarytoemphasizethecombinationwithstandardpatents,topayattentiontotheprotectionofpatentsinthetrendthattechnologybecomespatent,togiveadequateconsiderationofintegrationemergingfromthepatenttechnologyandexistingindustrystandardsinpatentstandardizedstage,and,finally,inthestandardpermitphase,totranslatethestandardsintorealutilizationandapplythemwidelytoallpossibleaspects.Inaddition,thebuildingoftheindustrystandardconstructionmustbecoordinatedwiththestandardrateoftechnologicalinnovationdevelopment.Subsequently,inthestudyofthestandardoftheChinesetraditionalmedicineindustryinthemainbuildingofapluralistic,fromthetheoreticallevel,theauthorclarifiesthatthegovernmentshouldplayaleadingrole,enterprisesshouldplaythemainroleandIIIintermediaryorganizationsshouldplaytheroleofabridge.Onthisbasis,fromapracticalperspective,theauthoralsoexplainsthegovernment'sparticipationintheexistingstandardpolicy,whichpointedoutthedeficiencies.Inlightoftheaboveresultsfromtheindustry-standardconstructionofthethreefactorsperspective,andaccordinglydisplaysthepolicyrecommendationsthatwouldenhancetheprocessoftheChinesemedicineindustrystandards.KeywordsChinesetraditionalmedicineindustryStandarddirectionInterneteffectsTechnologicalinnovation_____“√”111.11.1.12001BA701A34A1.1.2(1)WHO402002515WHO701201.350080001505[1]22002116(2)TBT3ICT1.2923765612000200041.2.111996ISO/IECGB3935.11983GB/T3935.11996[2]2[3]DeJureDeFactoDavid2000Swann[4]defacto5transactioncostssearchcostGreshamsLaw1.2.21TimSimcoe[5][6]TushmanAndersonHendersonClark[7]6CompetenceDestroying[8]2[9][10]QWERTY71.2.3111—1/Swann811[11]1—11191.2.4[12]GLPGCP[13][14][15][16]1.310111.412280128071800FDA[17]2.1OTC196565/EEC48a(ii)19881990GMPGoodManufacturingPractice1993129903131997GLPFDA199410251996816FDA2000200220008(GuidanceforIndustryBotanicalDruProducts)FDA14FDA200521014763210KPNDS50611741969672231142.22.2.11519301953196319771985199019952000200581953531215651322521119632000534458902005551280HPLC2173122HPLC17564438HPLC412HPLCGCTLCSTLC6626722.2.2[18]200321211621GB/T15517.1-1995GB/T15517.2-1995GB/T15517.3-1995GB/T15517.4-1995GB/T15517.5-1995GB/T15517.6-1995GB/T17356.1-1998GB/T17356.2-1998()GB/T17356.3-1998GB/T17356.4-1998GB/T17356.5-1998GB/T18765-2002GB6938-1986(14)GB/T18672-2002()GB6264-1986GB6265-1986(3)GB6266-1986GB6941-1986GB6942-1986(3)GB18355-2001..200309172.2.3-204052-10132-1522552003712.32.3.1182.3.2[19]20002.3.3FDAFDA192033.13.1.1,,,,()[20],21[21],[22]qqeq0q1VqeKqe(1)K,0fqeqe22fqe0fqe0f00001Puqev(qe)-P2PqD-1(q)=V(qe)(1-q)3qeqPqVq)1qkfq1q4MC0qLqH310qHqLqL3—1qL23qH3.1.2GAPGLPGMPGCPGSP,.[23]24,,,[24]3.23.2.1[25]122533.2.2IntellectualProperty1967TRIPS26ISOIEC3.2.3[26]32273—2GAPGLPGMPGCPGSPGPPGEP283.33.3.13-3[27]3—333CPE2933CPCPEEAB3.3.21441R&D30314Swann[28]4.1SandlerandTschirchartFreeRide324.1.1SwannSwann41334—1GreshamGreshamSwannGMPeter.TheEconomicsofStandardization.http//(1)David1985(2)(3)344.1.2(1)GMPGMPGAPGLPGCPGSPGAPGMPGLPGCPGSP2354.24.2.13612regulatorycapture[29]33775604.2.21232001-20032002200264.724.1820.32200216.14[30]4384142199520014-120015004215030010020030040050060070080019951996199719981999200020014—105010015020025030035040045019951996199719981999200020014—2.()().2005394.34.3.1WTO14024.3.21253%65%70%[31]414255.15.1.1GAPGMPGLPGCPGSP2002435.1.219981980349020%2000175035520.711200400030[32]5.1.34405.1.4441035GLP5.25.2.15.2.2R&DR&D1R&D45R&D50R&DGDP51R&D525-1R&D2001R&DR&DGDP7527R&D2001R&D2.75—1R&D/2002200220012002200120012001R&DGERD15629221279497288271125GERD/GDP%123282309250220190296OECD2003/15-2R&D200120002000200020002000200026829278706053512252172322712121482720222323728254130133208266434327208-651861603303511351692530743316912639136273022811081769157R&DR&D2002OECD2003R&D20022467533Mansfield53755—3%%1986—19941975—19851986—19941975—19853127131719111417941145633221655888134915138920011

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