• 中国核心期刊数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

快速检索引用检索图表检索高级检索

管理实践

数智药监一体化平台在新疆药品智慧监管中的探索和应用

  • 潘威 ,
  • 刘峰 ,
  • 武宵宵 ,
  • 汪雨霏 ,
  • 何壁君
展开
  • 1.国家药品监督管理局信息中心,北京 100163;
    2.新疆维吾尔自治区药物警戒中心,新疆 乌鲁木齐 830054
潘威,男,工程师,研究方向:药品智慧监管

收稿日期: 2025-08-25

  修回日期: 2025-11-06

  录用日期: 2026-05-26

  网络出版日期: 2026-05-26

Exploration and Application of Digital Drug Supervision Integration Platform in Intelligent Drug Supervision in Xinjiang

Expand
  • 1.Center for information of National Medical Products Administration Beijing 100076, China
    2.The Pharmacovigilance Center of Xinjiang Urumqi Xinjiang Urumqi 830054, China

Received date: 2025-08-25

  Revised date: 2025-11-06

  Accepted date: 2026-05-26

  Online published: 2026-05-26

摘要

为探索药品智慧监管模式,提升药品监管效能,新疆维吾尔自治区药品监督管理局(以下简称新疆局)积极推进数智药监一体化平台(以下简称一体化平台)建设,推动监管模式创新,为保障公众用药安全提供了有力支撑。本研究在药品智慧监管推进必要性和新疆局建设一体化平台政策背景的基础上,全面介绍一体化平台建设目标、建设思路、总体架构,重点探讨新疆局一体化平台实践应用场景的建设成效。新疆局以一体化平台为抓手,采用“用新管”举措,通过智能审批、机器人巡检等构建全流程闭环,一网统全疆,提升监管精准性与效率;采用“放新用”举措,强化便民服务,实现行政审批全程电子化,提升企业办事便捷度与满意度;采用“称新办”举措,推动“两品一械”全生命周期追溯,依托“新疆药店”“普法+科普在线”等功能,结合数字化举报处置与风险预警,构建社会共治体系,提升政务服务效能。一体化平台在协同发力,推进“一网统全疆、一码溯全程、一心促发展”方面成效显著,实现了跨部门、跨业务数据互联互通,有效提升了药品监管数字化、智能化水平。

 

本文引用格式

潘威 , 刘峰 , 武宵宵 , 汪雨霏 , 何壁君 .

数智药监一体化平台在新疆药品智慧监管中的探索和应用

[J]. 中国医药导刊, 2026 , 28(4) : 497 -497-503 . DOI: 10.1009-0959.2026.050004

Abstract

 To explore the smart supervision model for pharmaceuticals and enhance the efficiency of drug regulation the Drug Administration of Xinjiang Uygur Autonomous Region hereinafter referred to as "Xinjiang Administration" has actively promoted the construction of the Digital and Intelligent Drug Supervision Integration Platform hereinafter referred to as "Integration Platform". This initiative drives innovation in regulatory models and provides strong support for ensuring public drug safety. Based on the necessity of advancing smart supervision for pharmaceuticals and the policy background of Xinjiang Administration's construction of the Integration Platform this study comprehensively introduces the objectives construction approach and overall architecture of the Integration Platform. It focuses on exploring the effectiveness of the practical application scenarios of Xinjiang Administration's Integration Platform. Leveraging the Integration Platform Xinjiang Administration adopts the "Use New to Manage" approach establishing a closed-loop process through intelligent approval and robotic inspection unifying the entire Xinjiang under one network and enhancing the precision and efficiency of regulation. It adopts the "Release New to Use" approach strengthening convenience services achieving full electronic administrative approval and enhancing the convenience and satisfaction of businesses. Furthermore it adopts the "Claim New to Handle" approach promoting the full lifecycle traceability of "two products and one device". Relying on functions such as "Xinjiang Pharmacy" and "Legal Popularization + Online Science Popularization" combined with digital reporting handling and risk early warning it builds a social co-governance system and enhances the efficiency of government services. The Integration Platform has achieved remarkable results in synergistic efforts to promote "unifying the entire Xinjiang under one network tracing the entire process with one code and promoting development with one heart". It has realized cross-departmental and cross-business data interconnectivity effectively enhancing the digitalization and intelligence level of drug regulation.


参考文献

      [1 中国共产党第二十次全国代表大全.中国共产党第二十次全国代表大会文件汇编[M.北京:人民出版社,202210.

         2  张耀祺.创新药品信息化监管 打造“智慧药监”新格局[J.中国市场监管研究,2018,(6):62-65.

         3  高理想,查镜凯,陈宇,等.智慧药品监管平台评价模型的构建与应用研究[J.沈阳药科大学学报,2021385):535-541.

         4  国家药品监督管理局.国家药监局关于印发《国家药品监督管理局关于加快推进药品智慧监管的行动计划》的通知[EB/OL.2019-05-24)[2024-06-05.https//www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20190524175201644.html.

         5  国家药品监督管理局.2025年全国药品监督管理工作会议在京召开[EB/OL.2025-01-08)[2025-03-14.https//www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/zhhyxx/20250108141233183. html.

         6  王君,刘锜,胡楠.新形势下药品生产智能风险预警模型的实践探索与思考[J.药学研究,2024438):828-832.

         7  郝晓雅,范晓倩,黄晓雪.河北省药品智慧监管体系建设研究[J.产业与科技论坛,2025247):216-218.

         8  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,2024267):643-649.

         9  牛颖泽,仇津海.浅谈食品药品监管工作信息化建设[J.中国药事,2013277):755-757.

         10 林明世.药品监督管理信息化建设的探讨[J.中国热带医学,200223):409-410.

         11 陈锋.药品安全穿透式监管探索研究[J.中国医药导刊,2025274):321-324.

         12 中国政府网.国务院办公厅关于全面加强药品监管能力建设的实施意见[EB/OL.2021-05-10)[2025-03-14.https//www.gov.cn/zhengce/content/2021-05/10/content_5605628.htm.

         13 夏莹,田顺平.探索利用大数据与智能化推进食品药品监管的思考[J.中国食品药品监管,2018,(6):71-74.

         14 安抚东.“互联网+”赋能药品监管现代化[J.中国食品药品监管,2023,(7):16-21.

文章导航

/