刘芬 吴浩 陈桂良 邱潇 史岚

    摘 要 《中华人民共和国疫苗管理法》的出台彰显了国家对疫苗实行最严格监管的决心，作为全球首部针对疫苗的法律，对疫苗驻厂监管也提出了非常严格的要求。但疫苗派驻工作的开展缺乏国际可借鉴的经验，国内相关的指导文件暂未建全，全国疫苗驻厂监管仍处于探索阶段。疫苗派驻检查工作推进1年有余，为更好地开展疫苗派驻检查，结合上海疫苗派驻检查工作实践，本文梳理了本市疫苗派驻工作推进经验、收获、仍面临的问题和改进建议，为疫苗派驻检查后续推进建立工作基础。

    关键词 疫苗管理法 疫苗驻厂检查 监管

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)15-0053-03

    Practice and thinking of Shanghai vaccine dispatched inspection work

    LIU Fen1， WU Hao1， CHEN Guiliang1， QIU Xiao2， SHI Lan2

    (1. Shanghai Center for Drug Evaluation and inspection， Shanghai 201203， China； 2. Shanghai Drug Administration， Shanghai 200233， China)

    ABSTRACT The promulgation of the law on vaccine administration demonstrates the countrys determination to carry out the strictest supervision of vaccines. As the worlds first law on vaccine administration， it also imposes strict requirements for vaccine on-site inspection. However， this work is still in the exploratory stage due to lacking relevant domestic guidance documents and international experience that can be used as reference. The vaccine on-site inspection in China has been carried out for more than one year and has made certain achievements. In order to better carry out vaccine on-site inspection and combine with the practice of vaccine inspection in Shanghai ......