远程视频检查在我国兽药监管领域的应用  

Application of Remote Video Examination in the Field of Veterinary Drug Supervision in China

作　　者：周晓翠 安洪泽[1] 陈莎莎[1] 谭克龙[1] 陆连寿[1] 张珩[1] 田春艳[1] 宫爱艳[1] 冯克清[1] 张欣玉[1] 吴涛[1] ZHOU Xiao-cui;AN Hong-ze;CHEN Sha-sha;TAN Ke-long;LU Lian-shou;ZHANG Heng;TIAN Chun-yan;GONG Ai-yan;FENG Ke-qing;ZHANG Xin-yu;WU Tao(China Institute of Veterinary Drug Control,Beijing,10081,China)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《动物医学进展》2023年第12期123-126,共4页Progress In Veterinary Medicine

基　　金：中国兽医药品监察所“兽药行业公益性重点专项”项目(GY202025)。

摘　　要：因受新冠肺炎疫情或动物试验场所动物防疫制度要求的影响,兽药GMP/GCP/GLP检查员无法赴被检查单位或其动物试验场所所在地开展现场监督检查工作的难题,农业农村部畜牧兽医局于2022年4月提出“兽药远程视频监督检查”新思路,创新监管方式,助力我国兽药生产企业早日获得生产许可资质,兽药研发机构尽快投入研发工作。论文详细介绍了我国兽药监管领域远程视频检查的背景和应用情况,对兽药远程视频检查的优势及存在的问题进行分析,并就远程视频检查的推广应用提出建议,为在农业农村系统行政执法中普及远程视频检查提供参考与借鉴。In order to overcome the problem that GMP/GCP/GLP inspectors for veterinary drugs are unable to carry out on-site supervision,which due to the impact of COVID-19 or animal quarantine requirements in animal testing sites,the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs launched an innovative method of“remote video examination of veterinary drugs”in April 2022.They help veterinary drug production enterprises to obtain production license and help the veterinary drug research institutions into research work as soon as possible.This paper introduces the background and application of remote video inspection in the field of veterinary drug supervision in China,analyzes the advantages and existing problems of remote video inspection,and puts forward suggestions on the promotion and application of remote video examination,providing reference for the popularization of remote video examination in the administrative law enforcement of agricultural and rural field.

关 键 词：兽药生产质量管理 兽药临床试验质量管理 兽药非临床研究质量管理 远程视频检查 兽药监管 应用 

分 类 号：S851.4[农业科学—预防兽医学] S851.33[农业科学—兽医学]