Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China＇s drug regulation.In addition,suggestions were provided to enhance the capacity of drug regulation,including a clearer functional positioning for drug regulation,increased resource inputs in drug regulation at central level,a more rational allocation of vertical drug regulatory functions,and an improved supervision mechanism for regulatory departments.
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.
