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I摘要大量‘重磅炸弹药物’专利过期以及全球金融危机和巨额医疗支出给各国财政带来的巨大压力可以说是仿制药得以快速发展的根本原因。接下来5年，美欧日等发达国家医药市场增速将放缓至1%～4%，这很大程度上与大量高价专利药专利过期转而由平价仿制药替代，而新药上市速度明显放缓分不开的，预计2011年至2015年的五年间约1200亿美元的专利药销售额将由220亿美元的仿制药代替，净损失980亿美元。过去的20年里，委托加工业务一直维持着两位数的增长，而这在接下来的5年里预计仍将持续一趋势。到2017年，全球药品委托加工业务预计将达到630亿美元，其中固体制剂的委托加工业务占比最大，预计将维持12.5％的年增长率，至2017年达550亿美元。‘医药企业通过国际认证，制剂产品取得美国或欧盟国家的上市资格，真正进入国际主流医药市场’被明确写在医药行业十一五和十二五发展规划中，而规范市场上市许可制度也为国内药企经济快捷的走出国门提供了一条相对低风险的道路。本文通过对国内药企现状的介绍，结合对两个国内药企实现制剂产品出口欧美市场典型实例的分析，论证了委托加工方式在现阶段国内药企制剂出口业务中所应起的重要作用。关键词：制剂出口；委托加工；药事法规；通用名药IITheImportantroleforCMOintheCurrentFinishedDosageProductsExportBusinessofDomesticPharmaceuticalCompaniesPatentexpireforalargenumberof‘blockbusterdrug’,aswellastheglobalfinancialcrisisandenormousfinancialpressurefromhugemedicalspending,areconsideredasthemajorfacotorstodrivethegenericdrugsindustrydeveloprapidly.Overthenextfiveyears,patentexpirieswillsavepayersinDevelopedmarkets$120Bn,offsetby$22Bnofexpectedgenericspendingforthesemedicines,resultingina$98Bnpatent‘dividend’intheseyears.Meanwhile,thelaunchingspeedofnewdrugsisalsoslowingdown.Thepharmaceuticalindustygrowthrateforregulatedmarket,suchasUS,westernEuropeandJapanwilldecreaseto1-4%.TheCMOindustryhasexperienceddouble-digitgrowthinthepasttwodecadesandthattrendisexpectedtocontinueforthenextfiveyears.By2017,thesizeoftheglobalcontractmanufacturingmarketisexpectedtogrowtoabout$63billion，andsoliddosageformulationremainsthelargestsegmentoftheCMOindustrybyrevenue.Thesoliddosagemarketisexpectedtoexpandoverthenextfiveyearsatanannualrateof12.5%andasmuchas$55billionwillbespentby2017onCMO-basedsoliddosagemanufacturing.‘Thepharmaceuticalindustryeleventh/twelvethfive-yeardevelopmentplanning’,issuedbyNDRC,clearlyindicatethepositivenationalpolicyfortheInternationalizationofdomesticpharmaceuticalcompany,encouragetheGMPcompliaceoffacilities,GenericdrugsapplicationinUSorEU.Comparedwith‘Productionauthorization’inChina,the‘Marktingauthorization’systeminUSandEUmaketheCMOwaymoreconvenientandeasier,andalsolowerrisk.ThroughthePresentsituationanalysisoflocalpharmaceuticalcompany,aswellastwocasestudy,wegottheconclusionofthispaper‘theCMOwayshouldplayaimportantroleintheFinishedDosageProductsExportBusinessforDomesticPharmaceuticalCompanies.Keywords:FinishedDosageProductExport,CMO,Pharmaceuticalaffairslawandregulations,GenericDrugProducts目录III第1章前言.............................................................................................................................................11.1研究背景.............................................................................................................................................11.2研究目的和意义.................................................................................................................................11.3研究设计.............................................................................................................................................11.3.1数据来源..........................................................................................................................................11.3.2研究方法..........................................................................................................................................1第2章全球仿制药市场分析.................................................................................................................32.1专利药过期高峰带来的仿制药市场扩容.........................................................................................32.4医药新兴市场的快速崛起............................................................................................................7第3章制药业委托加工业务的现状及发展前景...............................................................................103.1全球药品委托加工业务概述...........................................................................................................103.2药品委托加工业务的区域分布.......................................................................................................103.2.1概述................................................................................................................................................103.2.2美国和西欧规范市场药品委托加工业务....................................................................................103.2.3中国市场药品委托加工业务........................................................................................................133.2.4药品委托加工业务的驱动力........................................................................................................14第4章制剂委托加工出口相关的国内国际现行法规解读...............................................................164.1欧美上市许可制度更有利于委托加工出口业务的开展...............................................................164.1.1概述................................................................................................................................................164.1.2中国生产许可制度对委托加工业务的限制作用.......................................................................164.1.3欧美上市许可制............................................................................................................................194.1.4欧美上市许可制与中国生产许