我国疫苗风险管理模式探讨

Vaccine Risk Management in China

药品风险管理是围绕药品安全性问题开展的,通过上市前研究或上市后不良反应监测,完成药品风险评估、风险控制、风险审核和风险沟通的系统过程。疫苗作为一种特殊的药品,其风险管理尤为重要。本文分析了我国疫苗不良反应监测的现状及存在的问题,并参考国际先进经验,对我国疫苗风险管理模式进行了探讨。

Drug risk management is a process around drug safety, which including risk evaluation, risk control, risk review and risk communication, through premarketing study or postmarketing adverse drug reaction monitoring. Vaccine risk management is important, because vaccine is a special drug. In this paper, the situation and problems about adverse vaccine reaction monitoring in our country were analyzed. And the risk management in our country was researched referencing international best practices.