| WHO药品资格预审规划对我国制药企业国际化的启示 |
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| 引用本文： | 井春梅,肖爱丽,张力. WHO药品资格预审规划对我国制药企业国际化的启示[J]. 中国药事, 2011, 25(4): 402-404 |
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| 作者姓名： | 井春梅 肖爱丽 张力 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 摘 要： | 目的推广对WHO药品资格预审规划的认识,为我国医药产品走向国际主流市场提出相关策略。方法通过分析WHO药品资格预审规划机构工作程序,从不同角度阐述药品资格预审规划的重要性。结果与结论深入学习国际组织相关法规和技术要求、建立符合国际标准的药品质量管理体系,是有效推进我国制药企业产品参与相关项目国际采购、早日进入国际市场的最佳途径。
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| 关 键 词： | 世界卫生组织 药品资格预审规划 工作程序 药品国际化 策略 |
Introduction of WHO Prequalification Program and Inspiration for the Internalization of Domestic Pharmaceutical Manufacturers |
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| Jing Chunmei,Xiao Aili,Zhang Li. Introduction of WHO Prequalification Program and Inspiration for the Internalization of Domestic Pharmaceutical Manufacturers[J]. Chinese Pharmaceutical Affairs, 2011, 25(4): 402-404 |
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| Authors: | Jing Chunmei Xiao Aili Zhang Li |
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| Affiliation: | Jing Chunmei,Xiao Aili and Zhang Li(Center of Drug Reevaluation,SFDA,Beijing 100045) |
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| Abstract: | Objective Spread awareness about the WHO prequalification program,and propose the related strategies for our pharmaceutical products into the international mainstream market.Methods Analyze the significance of WHO prequalification program in different respects,through introducing the program in terms of its organization structure,purpose,strategy and procedure,then put forward the inspiration.Results and Conclusion In order to effectively promote the domestic pharmaceutical products to be involved in the in... |
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| Keywords: | WHO prequalification program procedure drug internationalization strategy |
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