“十四五”时期药品安全监管相关政策分析与比较  

Policy analysis and comparison related to drug safety supervision during the “14th Five-Year Plan” period

作　　者：唐湘燕 曹永芳 何辉 TANG Xiang-yan;CAO Yong-fang;HE Hui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100061,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100061

出　　处：《中国新药杂志》2024年第7期644-650,共7页Chinese Journal of New Drugs

摘　　要：人民健康是民族昌盛和国家强盛的重要标志。为保障人民健康、促进医药产业走高质量发展道路,我国先后发布了“十四五”时期的规划、纲要,针对国家药品安全、医药工业、中医药发展、市场监管等方面提出一系列重要政策和措施。本文围绕《“十四五”国家药品安全及促进高质量发展规划》,系统梳理相关国家部委针对“十四五”所发布有关药品安全监管的相关内容,并对其进行分析和比较,以期更好地理解国家层面对药品安全监管政策的整体规划和制定脉络。The health of people is one of the important symbols of national prosperity.In order to ensure people's health and promote the high-quality development of the pharmaceutical industry,the plans and outlines for the “14th Five-Year Plan” were issued by the Chinese government,and a series of important policies and measures were put forward for the national drug safety,the development of traditional Chinese medicine,and market supervision.In this paper,based on the 14th Five-Year National Drug Safety and Promotion of High Quality Development,we systematically summarize the contents of drug safety supervision raised by related Chinese national ministries and commissions.We also analyze and compare the related contents,in order to better understand the national level of drug safety supervision policy of the overall planning and context.

关 键 词：药品安全 “十四五”规划 高质量发展 监管现代化 

分 类 号：R95[医药卫生—药学]