ForeignInvestmentInChinesePharmaceuticalSectorpharma-词缀:PharmaceuticPharmacology:biologyPharmacist:Scientist,chemistDespiteproblemsofcultural,ethicalandregulatorydifferences,agrowingnumberofforeigncompanieshavebegunmulticentrePhaseIIIclinicaltrialsinChina.Clinicaltrials•ClinicaltrialPhase:Ⅰhealthysubjects:effectsonbodyfunctions,dosedefinition,pharmacokinetics•Clinicaltrialphase:Ⅱselectedpatients:effectsondisease;safety,efficacy,dose,pharmacokinetics•ClinicaltrialphaseⅢ:patientgroups:comparisonwithstandardtherapyFDAapproval•Clinicaltrialphase:Ⅳgeneraluse:long-termbenefit-riskevaluationAftersomeinitialhesitation,WesternpharmaceuticalmanufacturesarerushingtothePeople'sRepublicofChinatoestablisha“presence”justafewyearsago.ThismeantopeninganofficeinBeijingorShanghaitoselltheirinternationallyapprovedproductstothegrowingChinesemarket.中国制药行业的外资情况尽管存在着文化、种族和法规的差异,越来越多的外国公司开始在中国进行多个实验中心的三期临床实验。经历了短暂的犹豫之后,就在这些年,西方制药公司纷纷涌入中国建立了其“基地(办事处)”。这就意味着在他们在北京、上海开辟一个办事处向不断增长的中国市场销售他们国际认证的产品。Nolonger."IfyouareseriousabouttheChinesemarket,youhavetocomehereasafullpharmaceuticalcompany,"saysDr.RossHorsburgh,regionalmedicaldirectorforBeijing-basedZenecaSinoPharmDevelopmentConsultingCompany,ajointventurebetweenBritain'sZenecaPharmaceuticalsandChina'sSino-Pharm."Youcan'tcomeherejustasasalesoutfitorjustasadistributionchannel."ThebasicmeansofChina'sabsorptionofforeigninvestments1.Sino-foreignjointventures2.Cooperativebusinesses3.Exclusivelyforeign-ownedenterprises4.Jointexploitation5.Foreign-fundedshare-holdingcompanies6.Newtypesofforeigninvestment中国制药行业的外资情况中国制药行业的外资情况现在的情况不是这样的了。“如果你对中国市场还心存疑虑的话,你可以以一个完整的制药公司来中国。”RossHorsburgh这样说,他是捷利康中国医药集团发展顾问公司北京区制药总监。该公司是英国捷利康和中国医药集团总公司共同设立的合资企业。他还说到:“你到中国来已经不能仅仅作为一个销售组织或者分散产品的渠道了。”WhenMDSHarris,theCanadian-ownedcontractresearchorganization,openedanofficeinChinain1993,theinterestbyUSandEuropeanpharmaceuticalcompaniesindoingsomethingmorethanasmallPhaseIVtrialtomeetChina'sminimallicensingcriteriawasmodestatbest,saysDrJamesMcClurg,theCRO'sPresidentandChiefExecutiveOfficer.Inthepasttwoyears,theinteresthas"increasedexponentially",hesays."Today,theinterestinChina,andinconductingclinicaltrialsinChinatotheWesternstandard,isquitefranklyoverwhelming.It'saverybroadinterestbymajordrugcompanieseverywhereintheworld,"hesays.Namecard:Namecard:Chairman:executivechairmanStockholder;CEO:chiefexecutiveofficeInspector;DirectorManager:generalmanagervicemanager中国制药行业的外资情况中国制药行业的外资情况“当加拿大国有契约研究组织(CRO)MDSHarris于1993年首次在中国设立办事处以来,美国和欧洲的制药公司开始对此投入的关注远远超出了仅仅是在中国做一些简单的四期临床实验以符合中国市场的最低要求”。作为CRO的主席和首席执行官(CEO)的JamesMcClurg博士说。“在过去的两年,这样的关注迅速扩大。今天,在中国进行的临床实验水平,坦率地讲,已经超过了西方标准。这将是世界各大制药企业广泛关注的事实。”Backin1980,Tokyo'sOtsukaPharmaceuticalcreatedthefirstSino-foreignpharmaceuticaljointventure:ChinaOtsukaPharmaceutical.Itwasfollowedin1982bySweden'sPharmacia,whichsetupthefirstEuropeanjointventure:...