首页|河南省药品生产智慧监管"千里眼工程"的建设与思考

河南省药品生产智慧监管"千里眼工程"的建设与思考

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为了落实国家药监局对药品智慧监管的统一部署,提升药品生产环节智慧化监管水平,提高药品质量安全保障能力,河南省药监局在考察学习部分省份药品智慧监管建设的先进经验的基础上,结合河南省药品生产企业信息化建设实际,印发并组织实施了河南省药品生产智慧监管方案.至目前,已构建了以批记录关键数据平台建设、远程视频监控平台建设、移动检查App开发为主要内容的河南省药品生产智慧监管"千里眼工程",现已覆盖全省除药用辅料外的所有药品生产企业356家.经过一年多的应用,所构建的"千里眼工程"虽然存在诸多不足与挑战,但是已能够满足监管人员开展药品生产现场远程检查工作需要,实现了全天候、全时段、全过程的无纸化药品远程智慧监管,有效解决了药品监管人员少、监管对象多、监管效率低等问题,已成为监管人员现场检查的有益补充.
Construction and Reflections on the"Thousand-Mile Vision Project"of Intelligent Supervision of Medical Production in Henan Province
In order to implement the National Medical Products Administration's unified deployment of intelligent drug supervision,enhance the smart regulatory level in the drug production process,and improve the ability to guarantee the quality and safety of drugs,Henan Medical Products Administration,based on learning from the advanced experiences of intelligent drug supervision in other provinces and considering the actual situation of information construction in drug production enterprises in Henan Province,has issued and implemented the smart regulatory plan for drug production in Henan Province.The"Thousand-Mile Vision Project"for intelligent supervision of drug production in Henan Province has been established,focusing on"the construction of key data platforms for batch records,remote video monitoring platforms,and the development of mobile inspection App".It has already covered 356 drug production enterprises across the province except for medicinal auxiliary materials.Despite the deficiencies and challenges encountered during its implementation,the"Thousand-Mile Vision Project"has enabled regulatory personnel to carry out remote inspections of drug production sites and realize paperless remote intelligent supervision of drugs round the clock,throughout the period,and throughout the process.It has effectively addressed issues such as limited drug regulatory personnel,numerous regulatory objects,and low regulatory efficiency,serving as a useful supplement to on-site inspections by regulatory personnel.

medical productionintelligent supervisionThousand-Mile Vision Projectconstruction statusshortcomings

陈世伟

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河南省药品监督管理局

药品生产 智慧监管 千里眼工程 建设情况 存在不足

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(5)
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