国外疫苗安全监管措施比较及对我国的启示

Comparison of vaccine safety regulatory measures in foreign countries and their enlightenment to China

疫苗是人类对抗疾病的重要屏障,是降低死亡率的有效工具,其安全性至关重要。近年来,我国疫苗安全事故层出不穷,我国对疫苗安全的监管能力有待提高。本文通过对国外疫苗安全监管措施进行总结和分析,从中得出对我国疫苗安全管理的启示,如设立统筹和协调各疫苗监管机构的综合管理部门、构建疫苗全过程的监管制度、加强疫苗的售后服务、健全与完善疫苗研发生产监管立法、完善疫苗伤害补偿机制等。

For human,vaccine is an important barrier against infectious diseases and an effective tool to reduce mortality.The safety of vaccine is of paramount importance.In recent years,China′s vaccine safety accidents have emerged in an endless stream,and China′s regulatory capacity for vaccine safety needs to be improved.The study summarizes and analyzes the vaccine safety supervision measures in foreign counties and draws inspirations for China′s vaccine safety management,such as setting up a comprehensive management department for coordinating various vaccine regulatory agencies,establishing a regulatory system for the whole process of vaccine production,strengthening after-sale service for vaccine,improving and perfecting the vaccine development and production supervision legislation,and improving the vaccine injury compensation mechanism.