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信息化条件下开展药品经营企业远程检查的模式研究

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目的 探讨利用信息化技术开展药品经营企业远程检查的模式.方法 对药品经营企业进行实地走访,对药品监管人员进行问卷调查,分析远程检查的适用范围,探索实施远程检查的程序方法,并提出相关建议.结果 通过问卷调查确认了适合开展远程检查的情况,以及不适合开展的风险点.现有信息技术在远程通讯、数据采集、数据交换等方面已基本满足开展远程检查的条件,但仍存在信息化系统建设滞后、数据安全性不高、信息化人才缺失等问题.结论 药品监管部门应建立健全信息化远程监管体系,加强数据安全保护,打造信息化检查员团队,提高审评查验效能,着力推动"互联网+药品流通"模式的蓬勃发展.
Model of Remote Inspection of Drug Trading Enterprises Under Information Technology Conditions
Objective To investigate the mode of remote inspection of drug trading enterprises by information technology.Methods On-site visits to drug trading enterprises and questionnaire surveys of regulatory personnel were conducted to analyze the scope of the remote inspection,explore the procedures and methods for implementing remote inspection,and provide relevant suggestions.Results Through the questionnaire survey,the suitable conditions for conducting remote inspections and the risk points that were not suitable for conducting them were confirmed.The existing information technology has basically met the conditions for conducting remote inspections in areas such as remote communication,data collection,and data exchange,but there were still problems such as lagging information system construction,low data security,and a shortage of information technology talents.Conclusion Drug regulatory authorities should establish and improve the information-based remote supervision system,strengthen data security protection,construct an information-based inspector team,improve the efficiency of review and inspection,and strive to promote the vigorous development of the"Internet + drug distribution"model.

information technologysmart regulationdrug trading enterprisesremote inspection

谢雄、唐红、杨航、江蓝、邹远军、郭文献

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重庆市药品技术审评查验中心,重庆 401120

信息化技术 智慧监管 药品经营企业 远程检查

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(9)
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