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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (9): 650-653.

所属专题: 智慧监管专栏

• 智慧监管专栏 • 上一篇    下一篇

以质量管理为突破的药品智慧监管新尝试——基于贵阳信息化案例分析

杜林林1, 梁毅2, 周亚娴1, 陶浪1, 李韬1, 李慧强3   

  1. 1. 贵阳市市场监督管理局, 贵州 贵阳 550009;
    2. 中国药科大学, 江苏 南京 210000;
    3. 江苏扬子易联智能软件有限公司, 江苏 南京 210000
  • 收稿日期:2020-11-09 修回日期:2020-06-09 出版日期:2020-09-29 发布日期:2020-11-10

New Attempt of Intelligent Drug Supervision Taking Quality Management as a Breakthrough: Based on the Informalization Case Analysis of Guiyang

  1. 1. Bureau of Guiyang Market Supervision and Administration, Guizhou Guiyang 550009, China;
    2. China Pharmaceutical University, Jiangsu Nanjing 210000, China;
    3. Jiangsu Yangzi Yilian Intelligent Software Co., Ltd., Jiangsu Nanjing 210000, China
  • Received:2020-11-09 Revised:2020-06-09 Online:2020-09-29 Published:2020-11-10

摘要: 随着信息技术的改革创新,信息化管理系统的建设为药品质量的智慧监管提供了更多可能。贵阳市市场监督管理局以监管科学与信息技术融合创新为基础,以大数据、云计算等信息技术为支撑,开创性地将质量管理作为药品监管突破点,构建GMP、GSP智慧监管平台,实现全市药品生产经营企业全面、实时、动态的风险感知预警,赋能企业推动药品行业共治,并通过动态监管规则库极大地降低系统维护成本。本文以贵阳市案例作为分析对象,总结其建设思路、总体框架、创新特色与典型应用,针对其中的优势与特点,进行分析与展望。

关键词: font-size:medium, ">GMP;GSP;质量管理;药品智慧监管;信息化

Abstract: With the reform and innovation of information technology, the construction of information-based management system provides more possibilities for the intelligent supervision of drug quality. Based on the fusion and innovation of regulatory science and information technology, and supported by big data and cloud computing, Bureau of Guiyang Market Supervision and Administration has pioneered quality management as a breakthrough point in drug supervision, constructed GMP and GSP intelligent supervision platform, and realized comprehensive, real-time, dynamic risk awareness early warning system, and empowered enterprises to promote the common governance of the whole industry, greatly reduced system maintenance costs through the dynamic regulatory rules library. This article takes the innovative application of the drug intelligence regulatory platform of Guiyang City as the object of analysis, puts forward the pioneering construction idea, the overall framework and the typical application, and analyzes the advantages and characteristics.

Key words: GMP; GSP; Quality management; Drug intelligent supervision; Informatization
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