CMO为中国制药工业国际化带来契机——CMO市场和流程解

III摘要中国制药业面临国际化的迫切需要。本文研究一条中国制药业国际化的快捷途径——合同加工（CMO）。本文分析了国际药品CMO的发展背景、市场和发展趋势，并分析了中国制药业国际化现状，阐述近年来不断增长的国际CMO市场给中国制药业国际化带来的良好机遇和各种有利之处，合同加工可以帮助解决中国制药企业国际化途中遇到的许多问题，弥补企业的不足，是一条国际化的捷径，中国制药企业需要抓住这个良好的机会。本文还重点分析了国际合同加工的一般流程及流程中各环节所涵盖的具体内容、技术要点、注意事项及相关欧美药事法规等，阐述制药企业成为CMO需要具备的基本条件，企业在合同加工过程中需要学习积累的国际化制药管理经验。最后介绍两种由CMO带动的中国制药业国际化的发展模式，供企业参考借鉴。关键词：合同加工，委托生产，生产外包，制药，原料药，制剂，国际化，流程4CMOBringstheChanceofglobalizationtoChinesePharmaceuticalIndustry-------CMOMarketandFlowchartAnalysisandGlobalizationModelStudyAbstractChinesepharmaceuticalindustryisfacinganurgentneedofinternationalization.CMOisafastandeffectivewayforglobalization.ThisarticlestudiesCMOincludingitsdevelopmentbackground,market,trendsandtheflowchart.ThisarticleanalyzestheinternationalCMOmarketandthestatusquoofChinesepharmaceuticalindustrytoexpatiatethatthegrowinginternationalCMOmarketisbringingthegoodchancetoChinesepharmaceuticalindustry.BeingaCMOcanhelptosolvemostoftheproblemsChinesepharmaceuticalindustrymetduringtheirlabourforglobalizationandmakeuptheweaknessoftheenterprises.CMOisashortcutforChinesepharmaceuticalindustryglobalization.Chinesepharmaceuticalenterprisesshouldgraspthisgoldenopportunity.Thisarticlelaysspecialstressonanalyzingthegeneralflowchartofinternationalcontractmanufacturing.Itintroducesthespecificcontentsthatarecoveredineachstepoftheflowchartsuchastechnicalpoints,mattersthatneedstobefocusedonandrelatedregulationsofEuropeandFDA.IthelpsthepharmaceuticalcompaniestounderstandthebasicrequirementstobecomeanattractiveCMOandhowtoaccumulatetheadvancedexperienceofinternationalpharmaceuticalmanagementduringthecontractmanufacturing.Finally,thisarticleintroducestwokindsofglobalizationmodelsdrivenbyCMOfortheenterprisereference.KeyWords：CMO,Outsourcing,Pharmaceutical,API,Formulation/Dosage,Globalization,Process/Flowchart,Procedure5目录第一章绪论...............................................................................................................11.1选题的理论意义与现实意义...............................................................................................11.2国内外相关研究成果述评...................................................................................................11.3目的......................................................................................................................................1第二章CMO的定义与服务范围.............................................................................32.1CMO的定义........................................................................................................................32.2CMO服务范围....................................................................................................................3第三章国际CMO现有市场规模及发展趋势........................................................53.1国际CMO发展背景............................................................................................................53.2国际CMO现有市场规模....................................................................................................63.3国际CMO市场分布............................................................................................................63.3.1原料药CMO市场分布................................................................................................63.3.2制剂CMO市场分布....................................................................................................73.4国际CMO发展趋势............................................................................................................83.4.1临床试验用材料的生产加大.......................................................................................83.4.2生物制药生产外包市场发展迅猛...............................................................................9第四章CMO给中国制药业国际化带来的契机...................................................104.1中国制药业国际化的现状分析.........................................................................................104.1.1中国制药业原料药的出口规模.............................................................104.1.2中国制药业制剂的出口规模.....................................................................................104.1.3中国制药业国际化现状分析.....................................................................................114.2CMO给中国制药业国际化带来的机遇...........................................................................124.3中国制药企业吸引合同加工的有利条件.........................................................................134.3.1生产成本低.................................................................................................................144.3.2GMP的依从性提高，硬件条件得以改善...............................................................144.3.3原料药规模大，品种多.............................................................................................144.3.4政策法规的完善.........................................................................................................15第五章CMO的一般流程介绍...............................................................................165.1CMO项目评估...................................................................................................................175.1.1寻找合适的CMO需要考虑的因素..........................