Introduction to drug regulatory capabilities: a theory and framework  

药品监管能力理论研究与模型框架（英文）

作　　者：杨松[1] 杨东升 郑晓元 黄果[3] 丛骆骆 江滨[1,5] 

机构地区：[1]北京大学药学院药事管理与临床药学系,北京100191 [2]药品研制和开发行业委员会,北京100004 [3]国家食品药品监督管理总局办公厅,北京10053 [4]北京市食品药品监督管理局,北京10053 [5]北京大学医药管理国际研究中心,北京100191

出　　处：《Journal of Chinese Pharmaceutical Sciences》2015年第4期257-262,共6页中国药学（英文版）

基　　金：National Social Science Fund(Grant No.13BGL141)

摘　　要：This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities（DRC） and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows： a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.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。

关 键 词：Drug regulatory agency Organizational capabilities Drug regulatory capabilities Regulatory performance 

分 类 号：R95[医药卫生—药学]