美国FDA药品安全信息公开及启示  

The US FDA drug safety information disclosure and its implication

作　　者：徐徕[1,2] 余伯阳[1] 杨依晗 

机构地区：[1]中国药科大学国际医药商学院,南京211198 [2]上海市食品药品安全研究中心,上海200233

出　　处：《中国新药杂志》2010年第20期1841-1846,共6页Chinese Journal of New Drugs

摘　　要：立足美国食品药品监督管理局(FDA)信息公开制度的发展和现状,阐述了FDA信息公开的依据、方式、内容和趋势及不足,并比较分析我国药品信息公开与美国药品信息公开的异同。研究结果显示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,借鉴美国较成熟的信息公开经验,重视风险管理体系及信息技术在药品安全信息公开中的作用,适时建立适合我国的药品安全信息发布机制,及时、准确、科学地发布药品安全信息,提升药监部门的公信力。Based on the development and status of the disclosure of information in US Food and Drug Administration（FDA）,this paper expounds the basis,access,content,tendency and the deficiency of the disclosure of drug safety information,in FDA,and compared it between State of Food and Drug Administration in China（SFDA） and FDA.The results show that there are many similarities between US and China in the disclosure of information.In view of the practical situation of governmental information disclosure in China,Chinese government should learn some experiences of US in the field.These include to value the importance of the risk management system and information technology,to establish our drug safety information dissemination mechanism in proper period,and to disseminate drug safety information timely,accurately and scientifically.This will enhance the credibility of drug administration department in China.

关 键 词：美国食品药品监督管理局 政府信息公开 药品安全信息 

分 类 号：R95[医药卫生—药学]