美国“Bolar例外”及首仿药制度的研究及对我国的启示

Research on "Bolar Exception" and the First Generic Drug System of USA and Its Enlightenment to China

目的:参照美国"Bolar例外"及首仿药制度的设立与发展,为我国仿制药制度的建立与完善提供参考建议。方法:采用文献调研和政策解读的方式进行内容提取,运用对比分析的方法进行制度研究。结果:我国在"Bolar例外"的适用范围与首仿药制度的建设方面还存在漏洞和缺失。结论:应不断完善我国"Bolar例外"的适用范围,加强首仿药制度建设,促进医药产业的持续健康发展。

Objective： To provide references and recommendations for the establishment and improvement of generic drug policy of China according to the establishment and development of ＂bolar exception＂ and the first generic drug of USA. Methods： Content was extracted using the method of literature research and policy interpretation. System was analyzed using the method of comparative analysis. Results： There were some loopholes and deficiences in the application scope of ＂bolar exception＂ and the establishment of the first generic drug system of China. Conclusion： The application scope of ＂bolar exception＂ of China should be continuously improved, the establishment of the first generic drug system of China should be strengthened, the sustained and healthy development of the pharmaceutical industry of China should be promoted.