超越监管看安全:国家药品安全治理体系构建
发布时间：2019-07-26 06:35
【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》。
[Abstract]:At present, there is a low level supply and demand structure in drug safety in our country. There are three deep-seated problems in the pattern of "big industry-weak supervision" and the coexistence of multiple risks. The linear supervision mode with permission, inspection and punishment as the main policy tools is difficult to adapt to, and must go beyond supervision to see safety. Based on the theory of overall governance, this study puts forward the framework of "goal-structure-action" to construct the national drug safety management system; redefines the objectives of drug safety management to solve the above problems from the strategic dimension of healthy China, public safety and supply-side reform; expounds the multi-agent organizational structure, analyzes the mechanism of cooperative management of departments, scientific division of administrative rights and supervision of embedded industries. Based on this, this paper puts forward an action plan of drug safety management around the three logical aspects of premise, process and result, and suggests that the National Drug Safety outline should be formulated as soon as possible.
【作者单位】： 国家行政学院社会和文化教研部;清华大学公共管理学院;清华大学公共管理学院中国公共管理案例中心;
【分类号】：F203
，
本文编号：2519398
[Abstract]:At present, there is a low level supply and demand structure in drug safety in our country. There are three deep-seated problems in the pattern of "big industry-weak supervision" and the coexistence of multiple risks. The linear supervision mode with permission, inspection and punishment as the main policy tools is difficult to adapt to, and must go beyond supervision to see safety. Based on the theory of overall governance, this study puts forward the framework of "goal-structure-action" to construct the national drug safety management system; redefines the objectives of drug safety management to solve the above problems from the strategic dimension of healthy China, public safety and supply-side reform; expounds the multi-agent organizational structure, analyzes the mechanism of cooperative management of departments, scientific division of administrative rights and supervision of embedded industries. Based on this, this paper puts forward an action plan of drug safety management around the three logical aspects of premise, process and result, and suggests that the National Drug Safety outline should be formulated as soon as possible.
【作者单位】： 国家行政学院社会和文化教研部;清华大学公共管理学院;清华大学公共管理学院中国公共管理案例中心;
【分类号】：F203
，
本文编号：2519398
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