远程监查在药品监管的应用与思考
1.南昌工学院,江西 南昌 330038;
2.江西省药品监督管理局,江西 南昌 330029
收稿日期: 2025-05-08
修回日期: 2025-08-06
录用日期: 2025-11-12
网络出版日期: 2025-11-18
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
目的:探索监管机构基于信息化条件下对药品经营企业实施远程检查的模式。方法:通过实地调研多家药品经营企业与监管人员,了解药品经营检查情况;通过发放问卷调查,收集关于药品经营企业远程检查存在的问题和建议。在此基础上,分析远程检查可能存在的问题及其产生根源,进一步探讨实施远程监查的策略。结果:尽管当前的信息技术在远程通信、数据收集与传输等方面已基本满足远程检查的需求,但在实践中仍面临一些挑战,包括信息系统建设滞后、数据安全防护能力不足以及信息化专业人才匮乏等问题。结论:药品监管机构应当致力于构建全面高效的信息化远程监管框架,强化数据安全防护措施,加强队伍建设,积极培养专业的信息化检查人员,提升审评与检查工作的效率。此外,应大力推进“复合检查”发展模式,促进药品行业的数字化转型与升级。
阴艳丽
,
徐仁恩
.
远程监查在药品监管的应用与思考
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.
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