基于史密斯模型的药品上市后安全性研究政策执行分析  

Implementation Analysis of Post-authorization Safety Study Policy Based on Smith Model

作　　者：明爱恋 陈清华 蔡明 俞双燕[1] MING Ai-lian;CHEN Qing-hua;CAI Ming;YU Shuang-yan(School of Economics and Management,Jiangxi University of Chinese Medicine)

机构地区：[1]江西中医药大学经济与管理学院

出　　处：《中国食品药品监管》2023年第1期54-59,共6页China Food & Drug Administration Magazine

摘　　要：目的:对药品上市后安全性研究(PASS)政策执行情况进行分析,为优化PASS政策提供参考。方法:基于史密斯模型,从理想化政策、执行机构、目标群体、政策环境等4个影响因素出发,定性分析PASS政策执行情况。结果:通过史密斯模型的4个变量对PASS政策执行影响因素进行分析,建议完善PASS政策,出台PASS管理规范和条例;加强对PASS的监管,加大对PASS的投入;加强药品上市后风险管理;健全药品上市后安全性评价体系等。结论:随着新政策的出台,我国对药品上市后安全监测愈加重视,加强PASS有利于促进药品安全监管,更好保障公众健康及生命安全。Objective:To analyze the implementation of post-authorisation safety study(PASS)policy and provide reference for optimizing the PASS policy.Methods:Based on the Smith model,the PASS policy implementation is analyzed qualitatively from four influencing factors:idealized policy,implementation agency,target group and policy environment.Results:The analysis of the factors influencing the PASS policy implementation through the four variables of the Smith model,introduce the management norms and regulations of PASS;strengthen the supervision of PASS,increase the investment in PASS;strengthen the risk management after marketing;and improve the safety evaluation system after marketing.Conclusion:With the introduction of the new policy,China pays more and more attention to the safety monitoring of drugs after the market.Strengthening PASS can promote the supervision of drugs,so as to ensure the life safety of patients and public health.

关 键 词：药品上市后安全性研究 政策执行 史密斯模型 药品不良反应监测 药物警戒 

分 类 号：R95[医药卫生—药学]