数字政府建设与药品智慧监管顶层规划的研究与思考

Digital Government and Top-Level Planning for Drug Intelligent Supervision

数字政府建设是引领数字社会建设、加快数字化发展的必然要求。药品智慧监管以促进药品监管体系和监管能力现代化为目标,是数字政府建设在药品监管领域的具体体现,其建设目标就是以数字政府为大背景的“数字药监”。近年来,国家药品监督管理局发布多个药品智慧监管顶层规划文件。本研究从数字政府建设的背景出发,分析药品智慧监管与数字政府建设的内在联系,进一步明确药品智慧监管的建设理念,重点阐述药品监督管理局发布的药品智慧监管顶层规划文件的主要内容,归纳总结药品智慧监管的建设愿景,以期为相关从业人员提供借鉴参考。

The construction of digital government is an inevitable requirement to lead the construction of digital society and accelerate digitalization development.The goal of drug intelligent supervision is to promote the modernization of drug regulatory system and regulatory capacity,which is the concrete manifestation of the construction of digital government in the field of drug supervision.Its construction goal is“digital drug supervision”based on the background of digital government.In recent years,NMPA has issued a number of top-level planning documents for drug intelligent supervision.Starting from the background of digital government construction,this article analyzes the internal relationship between drug intelligent supervision and digital government construction,further clarifies the construction concept of drug intelligent supervision,focuses on the main content of the top-level planning document for drug intelligent supervision,and summarizes the construction vision of drug intelligent supervision.This article has certain reference significance for relevant practitioners.