关键词: 药品监管, 组织能力, 监管能力模型框架, 监管绩效

Abstract:

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.

Key words: Drug regulatory agency, Organizational capabilities, Drug regulatory capabilities, Regulatory performance