论文部分内容阅读
本文探讨了监管能力的定义、维度、构建机制及与绩效的关系。依据访谈、文献、五省三定方案调查的结果,药品监管能力的定义为:药品监管部门通过学习所形成的获取和重构组织资源和流程以实现保护和促进公众健康的模式。在研究框架上,监管能力可以分为资源整合能力、管理层决策能力、产品管理能力、检验检测能力等不同维度,结构上可以划分为基础性能力和职能性能力。研究介绍了三种适合于药品监管部门开展的药品监管能力提升机制:干中学、组织间学习、探索性学习。最后定性研究了中国药品注册审批能力和绩效的关系,发现资源整合能力和流程构建能力对绩效有正向影响。
This article explores the definition, dimensions, building mechanisms, and the relationship between performance and regulatory capabilities. According to the interviews, the literature and the results of the survey on the three plans of the five provinces and autonomous regions, the definition of drug regulatory capacity is defined as the mode of obtaining and reconstructing organizational resources and processes formed by learning by drug regulatory agencies to achieve the goal of protecting and promoting public health. In the research framework, the regulatory capacity can be divided into different dimensions of resource integration ability, management decision-making ability, product management ability, inspection and testing capability, and the structure can be divided into basic ability and functional capability. The study introduced three mechanisms for promoting drug regulatory capabilities that are appropriate for drug regulatory authorities: learning by doing, learning by doing between organizations, and exploratory learning. Finally, the relationship between the approval ability and the performance of drug registration in China is qualitatively studied. It is found that the ability of resource integration and process construction have a positive effect on performance.