美国FDA药品监管体系发展分析

Analysis on the Development of FDA Drug Regulatory System in US

目的:为发展和完善我国药品监管体系提供建议。方法:介绍美国FDA药品监管体系的发展,分析美国FDA监管系统改革举措。结果与结论:美国FDA药品监管体系建立了系统、连续的体系,监管方面的改革具有一定先进性和灵活性,我国可借鉴美国的相关经验,在监管体系改革过程中做出相关改进。

Objective: To provide suggestions for the development and improvement of drug regulatory system in China. Methods: Development of drug regulatory system of food & drug administration(FDA) in US was introduced, and the reforming measures of regulatory system of FDA in US were analyzed. Results and Conclusion: A systematic and continuous system has been established in the FDA drug regulatory system in US and the regulatory reform is advanced and flexible. Relevant experience of the United States should be learned and the corresponding improvements in the reforming process of the drug regulatory system should be made in China.