FDA药品安全监管体系的改革调整及启示

Reform Measures and Suggestion of the Drug Safety Supervision System of FDA

目的介绍FDA药品安全监管体系的改革措施。方法通过对FDA药品安全监管体系多方面的文献研究,介绍其体系的改革措施及美国政府问责办公室和美国医学会对该体系的评价报告。结果与结论对该体系组织机构的调整进行总结,研究其对我国的启示。

Objective To introduce the reform measures of the drug safety supervision system of FDA. Methods To research the drug safety supervision system of FDA in several ways, introduced the reform measures implemented by FDA and the evaluation reports from GAO and IOM. Results and Conclusions summarized organizations＇ restructuring of FDA.