欧盟公告机构介绍及对我国疫苗安全监管的启示

Introduction of EU notified body and enlightenment to vaccine supervision in China

疫苗作为一种特殊的预防性生物制品,被广泛应用于疾病预防和控制。近年来疫苗安全引起了社会公众的广泛关注,本文通过介绍欧盟医疗器械公告机构,探讨了我国疫苗监管制度以及如何借鉴欧盟做法在疫苗安全监管领域引入第三方机构的设想,以期为我国疫苗的安全监管提供参考。

As a special preventive biological product,vaccine is widely used in disease prevention and control.However,the frequent occurrence of vaccine safety incidents in recent years has aroused widespread concern among the public.This article introduces Notified Body in the European Union,and discusses the vaccine regulatory system and problems in China.Finally,it is recommended to introduce third-party institutional supervision measures in the field of vaccine safety supervision.