美国FDA药品上市后风险控制措施研究及对我国的启示——以沙利度胺为例

Research on post-marketing drug risk management measures of FDA and its implication for China--A case of thalidomide

风险控制是减低药品风险,减少患者伤害的关键步骤,是上市后药品风险管理的核心。美国已发展形成较为成熟的制度体系和一系列实施工具,而我国仍存在若干不足之处。本文主要选取毒性药物沙利度胺在美国重新上市的典型案例,分析其制定风险管理计划、采取风险控制措施的法律依据与过程,为我国发展有效的上市后风险管理制度提供参考借鉴。

Risk control is the key step to reduce drug risk and patient injury,and is the core of post-marketing drug risk management.FDA has developed a relatively mature system and a series of implementation tools,but the regulations in our country still needed to be improved.This paper mainly selects the typical case of thalidomide relisting in the United States,analyzes the legal basis and implementation process of its risk management plan and risk control measures,and provides a reference for China to develop an effective post-market risk management system.