疫苗派驻检查员制度在广东省的实践与展望

Practice and Prospect of Vaccine Resident Inspectors System in Guangdong

我国对疫苗产业实行最严厉的监管,2019年颁布的《疫苗管理法》要求省级药品监管部门必须选派检查员入驻疫苗上市许可持有人。在法规的要求下,广东省自2019年开始实施疫苗派驻检查员制度,并已取得初步成功。本文将从成果、创新、意义等方面对广东省疫苗派驻检查员制度的实施情况进行梳理,总结相关经验,并对未来完善该制度的方向进行讨论与展望。希望能为该制度在其他省份的实施提供一定的参考价值,以助推该制度的完善,强化我国疫苗监管。

China implements the strictest regulations for the vaccine.The Vaccine Administration Law issued in 2019 requires that provincial drug administration must dispatch inspectors to reside in vaccine marketing authorization holders.Under the requirements of the law,Guangdong Province has implemented a system of vaccine resident inspectors since 2019,and has achieved initial success.This paper will sort out the implementation of this system from the aspects of the current situation,significance,innovation,summarize the relevant experience,and discuss an outlook on the future directions to perfect the system.We hope this paper can provide some reference value for the implementation of the system in other provinces,helping push the improvement of the system and strengthen the regulation of vaccines in China.