国外创新药物临床试验不良事件赔付制度综述及启示

Analysis of the innovation drug adverse event relief system in developed countries and its implications in China

目前,我国创新药物临床试验不良事件没有可以遵循的相关的法律法规,也没有形成统一的赔付标准,不良事件给受试者带来了一定的伤害。本研究梳理国际上较为成熟的临床试验不良事件赔付制度,对我国建立药品不良事件伤害补偿救济制度进行分析和探讨,并提出一些具体的思考建议。

Because lack of the law and unified compensation standards about compensation of innovation drug adverse events in China, the sufferers cannot get any compensation from the correlative responsibility party, lead to the sufferers take on the injured result. Based on reference to the other countries＆#39; experience, the author gives some suggestions to how to set up innovation drug adverse events compensation system.