摘要
目的药品是保障人民生命健康的重要物资,具有区别于一般商品的特殊属性。药品安全事关社会稳定和国家安全,药品治理水平是国家治理体系和治理能力现代化的重要方面,本文对构建国家药品治理体系进行研究。方法笔者通过研究国内外药品治理领域研究成果,概述了国家药品治理体系的内涵和特点,梳理了在药品治理方面表现优秀的主流国家和新兴国家的治理经验,结合我国药品治理发展现状,提出目前存在的问题。构建国家药品治理体系框架模型,并分析各构成要素以及要素相互关系。结果通过分析发现,我国药品治理体系存在管理职能碎片化、社会参与度较低、监管效能不高等问题。结论下阶段我国应构建统一权威高效的国家药品治理体系,加强监管制度顶层设计,引入多元参与的社会共治模式,发挥学会协会桥梁作用以及保险机制在药品治理中的作用。
OBJECTIVE Drug is an important goods and materials for safeguarding people’s life and health,and has special attributes different from general commodities.Drug safety concerns social stability and national security.Drug governance level is an important aspect of modernization of national governance system and capacity.This paper studies the construction of national drug governance system.METHODS By researching the domestic and foreign research achievements in the field of drug governance,this article summarizes the connotation and characteristics of national governance in the field of medicine,and the governance experience of mainstream countries and emerging countries with excellent performance in drug governance.Combining with the current situation of China,the author proposes some problems.Constructing the framework model of national drug governance system,and analyzing the constituent elements and their mutuality of the national governance system in the pharmaceutical field.RESULTS The author proposes that China’s drug governance system has the problems of fragmentation of management functions,low social participation and low regulatory efficiency.CONCLUSION Some suggestions of next stage are put forward for the modernization of China’s national governance system and governance capacity in the pharmaceutical field.Through the research,China should build a unified,authoritative and efficient national drug governance system,strengthen the top-level design of the regulatory system,introduce a multi-participatory social governance model,and give play to the role of association and insurance mechanism in drug governance.
作者
李峰
吴晓明
LI Feng;WU Xiao-ming(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Center for Drug Evaluation,NMPA,Beijing 100022,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2019年第2期158-162,共5页
Chinese Pharmaceutical Journal
关键词
药品
治理体系
治理能力
pharmaceutical
national governance system
governance capacity
