超越监管看安全：国家药品安全治理体系构建  

Beyond the Regulation:National Drug Safety Governance System in China

作　　者：胡颖廉[1] 慕玲[2,3] 

机构地区：[1]国家行政学院社会和文化教研部 [2]清华大学公共管理学院 [3]清华大学公共管理学院中国公共管理案例中心

出　　处：《中国行政管理》2017年第6期115-120,共6页Chinese Public Administration

摘　　要：当前我国药品安全存在低水平供需结构、"大产业—弱监管"格局、多元风险并存三大深层次问题,以许可、检查、处罚为主要政策工具的线性监管模式已难以适应,必须超越监管看安全。本研究基于整体治理理论提出"目标—结构—行动"框架,构建国家药品安全治理体系;从健康中国、公共安全、供给侧改革的战略维度,重新界定药品安全治理目标以破解上述问题;阐述多主体组织结构,分析部门协同共治、科学划分事权、监管嵌入产业的机理。据此围绕前提性、过程性、结果性三个逻辑层面,本文提出药品安全治理行动方案,并建议尽快制定《国家药品安全纲要》。Recent years witnessed some structural contradictions concerning drug safety in China, which cannot be resolved by linear regulation model. Based on holistic governance theory, this article advocates ＂Mission- Structure-Action＂ framework to construct a national drug safety governance system. Strategic perspectives including Health China, public safety and supply-side structural reform are introduced to redefine policy goal of drug safety. After exploring the mechanism of government departmental collaboration and regulation embedding in industry, drug safety governance action plans are followed by and could be a reference to the ＂National Drug Safety Scheme＂ .

关 键 词：药品安全 政府监管 健康中国 整体治理 “十三五”规划 

分 类 号：F203[经济管理—国民经济]