美国仿制药管理的法制历程及其对我国的启示

Legal Course of Generic Drug Management in USA and Its Enlightenment to China

介绍美国政府20多年来针对仿制药管理的主要法规,分析我国仿制药管理的现状。通过比较,提出了完善我国仿制药法制化管理的建议。

The current situation of generic drug management in China is analyzed by introducing the regulations of generic drug management of the recent 20 years of US government. Suggestion for the improvement of the legalized management of Chinese generic drug is made based on comparison.