WHO药品资格预审规划对我国制药企业国际化的启示  

Introduction of WHO Prequalification Program and Inspiration for the Internalization of Domestic Pharmaceutical Manufacturers

作　　者：井春梅[1] 肖爱丽[1] 张力[1] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药事》2011年第4期402-404,共3页Chinese Pharmaceutical Affairs

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。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 international procurement and enter the international market as soon as possible,the best ways might be as follows： to understand and pay close attention to the significance of attending the prequalification program,to learn further the relevant regulations of international organization and requirements of technology,to form the system of drug quality management which meets the international standards.

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 

分 类 号：R95[医药卫生—药学]