美国简明药品申请程序及相关法律责任  

American Abbreviate New Drug Application Procedure and Juridical Penalty

作　　者：张苏琳[1] 冯国忠[1] 陈永法[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京210009

出　　处：《中国药事》2003年第11期711-713,717,共4页Chinese Pharmaceutical Affairs

摘　　要：简明药品申请是美国仿制药品的研制和生产者向美国FDA提出药品上市的一种申请,其申请程序及相关的法律责任对我国仿制药品申请管理制度的完善和发展有着借鉴意义。Abbreviate New Drug Application is an application submitted to FDA for generic drug marketing by the applicants that plan to develop and product generic drugs. This paper introduced the application procedure and juridical penalty in generic drug marketing application of FDA. It is important to develop and perfect the management system in generic drug marketing application of our country.

关 键 词：简明药品申请 仿制药品 

分 类 号：R95[医药卫生—药学]