摘要
目的加强我国药品专家审评委员会的管理并促进其有效发挥作用。方法通过介绍美国FDA对药品咨询委员会的管理,利用文献回顾和对比分析的方法探索我国药品专家审评委员会需要改善的方面。结果与结论合理设置专家成员、强化对专家委员利益冲突的管理、增加委员会工作程序的透明度并加强委员会网站的建设,将有利于发挥我国药品专家审评委员会在药品审评中的作用。
Objective To strengthen the regulation of evaluation committee and exert its function effectively in China. Methods By introducing FDA regulation of advisory committees, then retrospecting documents and analyzing comparably to research the aspects, which will needed to improved in our evaluation committee. Results and Conclusions Establishing the appropriate evaluation committee members, strengthening the regulation of conflict of interest for evaluation committee members, enhancing the transparency of process, and building website will help the committee exert its function in drug evaluation.
出处
《中国药事》
CAS
2009年第3期303-306,共4页
Chinese Pharmaceutical Affairs
