美国仿制药审批管理体系初探  

Research on approval and regulatory system of generics in USA

作　　者：张宁[1,2] 平其能[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京210009 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药与临床杂志》2010年第5期387-393,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：从仿制药管理法规、仿制药技术评价体系、仿制药注册审批实施体系和有关配套管理政策4个层面对美国仿制药审批管理体系进行介绍和分析。美国仿制药审批管理体系的不断完善促进了仿制药产业的长足发展,对保证公众健康和降低医疗支出具有重要作用。The approval and regulatory system of generics in the United States was analyzed based on four aspects： the revolution of regulations related to generics,the formation of the technical evaluation system of generics,the optimization of the registration and approval system related to generics,and the support of matching administrative policies.With the amelioration of the system,the generics industry in the United States made considerable progress and contributed a lot to improve human health and decrease health care expenditure.

关 键 词：仿制药 立法 药物 技术评价 药物批准 卫生政策 

分 类 号：R951[医药卫生—药学]