美国FDA信息公开简述及启示

Brief Introduction on the Disclosure of FDA Information in US and Its Implication

目的:为我国食品药品监督管理部门开展信息公开工作提供参考。方法:立足美国食品与药品管理局(FDA)信息公开制度的发展和现状,阐述FDA信息公开的方式、内容和程序。结果与结论:中美药监部门信息公开有很多共性,我国可结合本国药监部门政府信息公开的实际情况,从FDA信息公开的发展、方式、内容和程序中发现我国实施信息公开应注意的问题,如信息公开效果需要人力和财力支持,公开水平应符合国情,应建立对不同级别政府信息的立体公开体系,重点研究重点公开信息等。

OBJECTIVE： To provide reference for food ＆ drug regulatory authorities in China to disclose government information. METHODS： In the light of the development and status quo of the disclosure of information in US FDA, the access, content and procedure for the disclosure of information in FDA were discussed. RESULTS ＆ CONCLUSIONS： There are many similarities between US and China in the disclosure of information. In view of the practical situation of governmental information disclosure in food and drug regulatory authorities in China, Chinese government should be able to find out such key issues as the human and financial support is much needed in FDA information disclosure, the disclosure level should be in line with our national condition, a three - dimensional publicity system of government information at different level should be established and emphasis should be laid to the key disclosed information etc based on the research on the development, access, content and procedure of information disclosure in FDA.