From Decentralised Developmental State Towards Authoritarian Regulatory State: A Case Study on Drug Safety Regulation in China

This paper attempts to answer three questions about the contemporary Chinese drug safety regulation system: why did the Chinese government reform its drug safety monitoring system and build a regulatory regime at the end of the 1990s? What obstacles will it face? What unique characteristics does it possess? Was it the collapse of the Interest Community of Government, Enterprise and Shiye Unit (ICGES) that fostered the rise of the regulatory regime in contemporary China's drug safety monitoring field? Three major structural obstacles threaten the building of a high-quality regulatory regime: problematic regulatory independence caused by decentralised developmentalism, an administration-reliant regulatory style and rent-seeking corruption brought about by the authoritarian political system. The author is inclined to characterise the current Chinese drug safety regulatory regime as an "authoritarian regulatory state" and argues that Chinese drug safety regulatory regime-building is still a work in progress.