CHINESE JOURNAL OF MEDICINAL GUIDE >
Application and Thinking of Remote Monitoring in Drug Regulation
Received date: 2025-05-08
Revised date: 2025-08-06
Accepted date: 2025-11-12
Online published: 2025-11-18
Objective: To analyze the mode of remote inspection implemented by the regulatory agencies of drug distribution enterprises under the condition of informatization.Methods: Through field visits to multiple pharmaceutical distribution enterprises and regulatory personnel, we gained insights into the status of drug operation inspections. By distributing questionnaires, we collected feedback on issues identified during remote inspections of pharmaceutical businesses. Based on this analysis, we examined potential problems in remote inspections and their root causes, while further exploring strategies for implementing remote monitoring systems Results: The potential problems were examined remotely by means of questionnaires. Although the current information technology has been able to meet the needs of remote inspection in terms of remote communication, data collection and transmission, it still faces some challenges in practice, including the lagging pace of information system construction, insufficient data security protection and the shortage of information technology professionals.Conclusion: Drug regulatory agencies should establish a comprehensive and efficient digital remote supervision framework, enhance data security measures, strengthen team development by cultivating professional IT-certified inspectors, and improve the efficiency of regulatory reviews and inspections. Furthermore, they should actively promote the "comprehensive inspection" model to drive digital transformation and industry upgrading in the pharmaceutical sector.
YIN Yanli, XU Renen
.
Application and Thinking of Remote Monitoring in
Drug Regulation
[1] 谢雄,唐红,杨航,等.信息化条件下开展药品经营企业远程检查的模式研究[J].中国药业,2024,33(9):53-55.
[2] 陈雪园,王宇,沈泓,等.浙江省疫苗生产企业信息化系统常见缺陷及检查要点分析[J].现代商贸工业,2024,45(22):13-15.
[3] 刘菁,周滋晶,程玮璐,等.美国食品药品监督管理局对治疗良性前列腺增生的医疗器械监管要求分析[J].中国医学装备,2025,22(6):158-162.
[4] 李壮琪,许倩,张姝婷,等.药品国际监管协调的发展现状研究与思考[J].健康发展与政策研究,2024,27(5):417-424,431.
[5] 张晓方,于冰,龚瑛,等.中美欧药品监管机构去中心化临床试验指导原则比较研究[J].中国食品药品监管,2024,(8):90-99.
[6] 孙金瑶,吴方,郭鲁波,等.美国、欧盟、日本药品检查员培训体系建设的经验和启示[J].中国新药杂志,2025,34(2):130-137.
[7] 游小杰,樊卫,付文亮,等.国际药品检查合作计划对我国省级药品检查的启示[J].中国药业,2024,33(12):32-35.
[8] 鄢广.英美德日药品监管机构设置模式比较及启示[J].中国卫生法制,2023,31(4):54-58,71.
[9] 栾力介,田丽娟.我国药品生产企业信用监管法制建设存在的问题及对策研究[J].中国药事,2024,38(8):853-859.
[10] 刘强,毛振宾,黄哲.药品监管科学研究的现状、热点与趋势:基于文献计量分析[J].中国新药杂志,2024,33(12):1185-1193.
[11] 李海峰,侯玉磊,赵彩虹,等.山东省药品经营企业记录与数据管理缺陷问题分析及监管建议[J].中国食品药品监管,2024,(1):76-82.
[12] 王广平,沈侃,徐建龙.我国药物警戒数据共享与数据交换现状与发展分析[J].中国医药导刊,2024,26(8):790-796.
[13] 唐竹,刘勤,缪锦辉,等.远程监管在药品监管和企业管理的作用与实践[J].中国医药导刊,2024,26(7):643-649.
[14] 张春桃,熊磊,袁桂平,等.优化药品经营现代物流政策提升监管效能的几点浅见[J].药品评价,2024,21(5):521-524.
[15] 陈世伟.河南省药品生产智慧监管“千里眼工程”的建设与思考[J].中国食品药品监管,2024,(5):100-107.
[16] 聂淑华,涂明珠.多维度认识监管科学作用,推动药监工作高质量发展[J].中国药事,2024,38(11):1269-1274.
[17] 刘坦飞.黑龙江省药品监督管理干部人才培养平台建设研究[J].黑龙江医药,2024,37(4):816-818.
[18] 骆实,曹凤朝,韩亮.全球药品监管机构药品AI应用监管策略与方法[J].中国医药导刊,2025,27(2):128-134.
/
| 〈 |
|
〉 |