美国药品安全突发事件的预防与应对机制  

America's Emergency Precautions and Response Mechanism of Drug Safety

作　　者：何兵[1,2] 昌君[1] 

机构地区：[1]中国政法大学 [2]法学博士

出　　处：《中国政法大学学报》2008年第3期42-54,159,共14页Journal Of CUPL

基　　金：国家社科基金重大项目"法治背景下的社会预警机制和应急管理体系研究"阶段性成果

摘　　要：药品不同于一般的商品,一方面它关系着全民的健康与福祉;另一方面复杂的成分和高度专业化的使用又使得药品不良反应带来的安全隐患难以觉察,一旦爆发则不仅给用药患者的生命健康带来重大伤害,某种程度上甚至会造成社会公众的恐慌。因此对药品不良反应突发事件的预防与应对,是现代各国政府监管的重中之重。美国是最早开展药品安全监管的国家,而其以FDA为核心的药品安全监管体系,则以先进的监管模式、广泛的数据来源和灵敏的反应对策闻名于世,堪为模范。This article aims to conduct a preliminary study of the mechanism.The full text can be divided into three parts:the first part introduces America's complete system of drug safety from the perspective of organizational and monitoring system;the second part analyzes the two typical cases(Cerivastatin Event and Vioxx Event) reflecting advantages and disadvantages of the system;the third part is on a reflection and reconstruction of the existing system.This article attempts to fully demonstrate advantages and disadvantages of the monitoring mechanism of FDA drug safety.Its intention is to provide some experience and lessons for perfecting China 's emergency response mechanism of drug adverse reaction.

关 键 词：药品不良反应 召回 撤市 万络 

分 类 号：D971.2[政治法律—法学] DD912.1