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上海CMC培训 GMP IN CHINA--- Challenges & Opportunities

上海CMC培训 GMP IN CHINA--- Challenges & Opportunities

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时间：2019-10-20

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1、GMPINCHINAChallenges&OpportunitiesShanghaiFoodandDrugAdministrationCenterforCertification&EvaluationHuaZhangJune28,2010GMPChallengesandOpportunitiesOverviewofChinapharmaceuticalindustryImportanceofGMPfordevelopingpharmaceuticalindustryinChinaGMPtrendsinChina2

2、Overviewof ChinaPharmaceuticalIndustryStatusofChinaPharmaceuticalIndustry2004～2007100millionsofRMBSource:TheSouthernMedicalEconomyResearchInstitute,SFDA4SalesRevenueof ChinaPharmaceuticalIndustry-2007100millionsofRMBSource:TheSouthernMedicalEconomyResearchIns

3、titute,SFDA5100millionsofRMBSalesRevenueof ChinaPharmaceuticalIndustry-2007Source:TheSouthernMedicalEconomyResearchInstitute,SFDA6ProfitofChinaPharmaceuticalIndustry2007100millionsofRMBSource:TheSouthernMedicalEconomyResearchInstitute,SFDA7100millionsofRMBPro

4、fitofChinaPharmaceuticalIndustry2007Source:TheSouthernMedicalEconomyResearchInstitute,SFDA8Overviewof ChinaPharmaceuticalManufacturers-2007Source:SFDAUnit：Company9OverviewofInjectableProductsManufacturersinChina-2007Source:SFDA10SaleRevenuesConcentrationDegre

5、eofChinaPharmaceuticalIndustry2003~2005Source:The Industrial Map of Pharmaceuticals2006～200711Characteristicsof ChinaPharmaceuticalIndustryHighlydispersedLackofdiversityMostlygenericdrugsLowprofitwithintensivecompetitionWeakbrandNoglobalbusinessdevelopmentexp

6、eriencesAlotpotentialbutunstable12Dilemmasfacedby ChinaPharmaceuticalIndustryGapsinmanagementphilosophyandmethodologywithglobalstandardsNegativeeffectsofmedicinescandalsWeakR&Dcapability,absentofnewproductsIncreasingpressureinenergy,environmentprotectionUncer

7、taintyofmedicalinsurancepolicies132.GMPisveryimportantforDevelopmentofPharmaceuticalIndustryinChinaWeAreEnteringintoaNewEraHigheconomicgrowthofChinaImprovementofpeople’slivingstandardScientificinnovationisconsensusIncreasingattentionsandprotectionsofIntellect

8、ualPropertyGlobalizationGlobalharmonizationofdrugregulationsandstandards15WeAreEnteringintoaNewEraChinesemanufacturersbegintogobeyondlowcostIncreasingattentionstotechnologyanddesignImprov

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