浅谈我国原料药的美国之路

目的:提高我国原料药的国际认证水平,促进我国原料药更好地进入美国市场。方法:分析国际和国内原料药市场的现状和发展趋势,比较中美两国原料药注册申报管理方法的差异。结果与结论:应该发挥我国原料药的规模、产量、成本等优势,抓住机遇,借鉴和学习美国原料药的药物主文件管理模式,进军美国市场,促进我国原料药的发展。

Access of Chinese Crude Drug to the USA Market

OBJECTIVE: To enhance the internal authentication level of Chinese crude drugs and to facilitate Chinese crude drugs' access to USA market. METHODS: It analyzed the status quo and developmental tendency of crude drugs in both international and domestic markets and compared the difference between China and USA in registration and reporting of crude drugs. RESULTS & CONCLUSIONS: It should take advantages of the scale, output, low costs etc, grasp the chance, draw experiences from USA about the master file management mode of crude drugs, enter USA market and promote the development of Chinese crude drug industry.