疫苗派驻检查工作的实践与思考

Practice and reflection on vaccine dispatched inspection

2019年12月《中华人民共和国疫苗管理法》提出了药物监管部门向疫苗生产企业派驻检查员的要求,此文通过对国内外疫苗监督体系的比较,对上海3年来派驻检查工作实践情况进行梳理,总结相关经验,对未来还需完善和努力的方向进行讨论与展望.

In December of 2019,"The Law on Vaccine Administration of the People's Republic of China"requires drug regulatory administration to dispatch inspectors to stay at vaccine manufactures.This article compares the similarities and differences between domestic and foreign vaccine regulatory systems,summarizes the practical relevant experience of dispatched inspectors from Shanghai in the past three years.Then the further development and expectation of this supervisory system are discussed.