文章摘要
张波常,张玥,孙芳蕊,陆颖.我国药品生产场地编码管理可行性研究[J].中国药事,2023,(11):1221-1224
我国药品生产场地编码管理可行性研究
Feasibility Study on Coding Management of Drug Production Sites in China
投稿时间:2023-06-19  
DOI:10.16153/j.1002-7777.2023.11.001
中文关键词: 药品生产场地  场地编码  全生命周期  精细化监管
英文关键词: drug production site  site code  life cycle  refined supervision and management
基金项目:
作者单位
张波常 国家药品监督管理局信息中心北京 100044 
张玥 国家药品监督管理局信息中心北京 100044 
孙芳蕊 国家药品监督管理局信息中心北京 100044 
陆颖 国家药品监督管理局信息中心北京 100044 
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中文摘要:
      目的:推动我国药品生产场地编码管理,促进药品全生命周期数字化管理,提升药品智慧监管水平。方法:通过文献查阅、专家咨询和调查研究等方法,在国外药品生产场地编码管理现状、我国船舶和食品等行业生产场地编码管理及药品生产场地管理情况等基础上,分析我国药品生产场地编码管理的必要性和可行性。结果与结论:从制度保障、编码颗粒度、社会共治等角度提出建议,为我国药品生产场地编码管理工作提供参考。
英文摘要:
      Objective: To promote the coding management of drug production sites in China, promote the digital management of the entire lifecycle of drugs, and improve the level of intelligent drug supervision. Methods: The necessity and feasibility of the coding management of the drug production sites in China were analyzed, through literature review, expert consultation, and survey research, based on the current status of coding management of drug production sites in foreign countries, the coding management of production sites in industries such as shipping and food, and the management of drug production sites in China, etc. Results and Conclusion: This article puts forward suggestions from the perspectives of system guarantee, coding granularity, and social cogovernance to provide reference for the coding management of the drug production sites in China.
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