王佳静 于玲莉 陈一飞 曹萌

    摘 要 突发公共卫生事件频发导致现场检查工作无法正常开展，给各国药品监管部门带来了新的挑战。远程检查作为一种替代方法，逐渐成为了各国着重考虑的检查模式之一。为确保特殊时期本市药品检查工作的正常有序开展，本文调研了全球各先进监管部门的远程检查开展情况及经验做法，从我国国情及研发生产实际情况出发，探索形成了一套有针对性的远程检查模式，初步制定了相关制度，希望在不断总结实践经验的基础上，让该新型监管模式在未来各类技术监管中发挥更有价值的作用。

    关键词 突发公共卫生事件 远程检查 药品监管

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2023)09-0071-05

    引用本文 王佳静， 于玲莉， 陈一飞， 等. 国外远程检查监管经验研究及我市远程检查制度的探索与实践[J]. 上海医药， 2023， 44(9)： 71-75.

    Research on foreign experience in remote inspection supervision and the exploration and practice of remote inspection system in Shanghai

    WANG Jiajing， YU Linli， CHEN Yifei， CAO Meng

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT The frequent occurrence of public health events in recent years and the various constraints have made it impossible to carry out some of the on-site inspections， which have posed new requirements and challenges for national drug regulation， and the remote inspection mode has become one of the ways that regulators are focusing on. In order to ensure that the drug supervision and inspection work in Shanghai can be properly carried out ......