沈阳市“十四五”时期基于FMEA法的药品安全监管法制化研究  

Research on the legalization of drug safety supervision based on FMEA in Shenyang city during the 14th Five Year Plan Period

作　　者：王旭 何静 Wang Xu;He Jing(Shenyang Open University,Shenyang 110003,China;General Hospital of Northern theater command of the PLA,Shenyang 110000,China)

机构地区：[1]沈阳开放大学,沈阳110003 [2]北部战区总医院,沈阳110000

出　　处：《中国卫生法制》2022年第3期94-96,102,共4页China Health Law

基　　金：沈阳市科技协会2014年度重点课题“关于加强食品药品安全监管的对策建议”(Sxk-201323B)。

摘　　要：十九届五中全会以来,由于我国的疫情仍然严峻,食品药品安全监管成为非常重要的政府管理的一部分。药品生产近几年在全国范围内得到了长足的发展,但我国药品安全监管的发展和相关立法不同步,以致于政府对药品的安全监管有时会出现失控的情况。FMEA法(失效模式及后果分析)是一种系统化的具体工作技术,还是模式化的行为思考形式,如果在药品安全监管中广泛使用,还需要将有关的方法和流程用法律的方式确定下来。在对沈阳市“十四五”时期药品安全监管的现状和目标进行分析的基础上,介绍了FMEA法的具体应用和意义,最后对基于FMEA法的药品安全监管实现法制化的策略进行详细的解读。Since the Fifth Plenary Session of the 19 th Central Committee of the Communist Party of China,due to the severe epidemic situation in China,food and drug safety supervision has become a very important part of government management.Drug production has made great progress in recent years across the country,but the development of drug safety supervision is not synchronized with the relevant legislation in China.As a result,the government’s drug safety supervision sometimes gets out of control.FMEA(failure mode and consequence analysis)is a systematic and concrete work technology,and it is also a mode of behavior thinking.If it is widely used in drug safety supervision,the relevant methods and processes need to be determined by laws and regulations.Based on the analysis of the current situation and objectives of drug safety supervision in Shenyang city during the"14 th Five Year Plan"period,this paper introduced the specific application and significance of FMEA,and finally made a detailed interpretation of the strategy of legalization of drug safety supervision based on FMEA.

关 键 词：FMEA法 药品安全监管 法制化 

分 类 号：D902[政治法律—法学理论]