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

摘要

This paper attempts to answer three questions about therncontemporary Chinese drug safety regulation system: why did thernChinese government reform its drug safety monitoring system andrnbuild a regulatory regime at the end of the 1990s? What obstacles willrnit face? What unique characteristics does it possess? Was it the collapsernof the Interest Community of Government, Enterprise and Shiye Unitrn(ICGES) that fostered the rise of the regulatory regime in contemporaryrnChinas drug safety monitoring field? Three major structural obstaclesrnthreaten the building of a high-quality regulatory regime: problematicrnregulatory independence caused by decentralised developmentalism, anrnadministration-reliant regulatory style and rent-seeking corruptionrnbrought about by the authoritarian political system. The author isrninclined to characterise the current Chinese drug safetyrnregulatory regime as an "authoritarian regulatory state"rnand argues that Chinese drug safety regulatoryrnregime-building is still a work in progress.