构建中国药品安全风险治理体系

The Construction of Drug Safety Risk Governance System in China

现代药品安全风险具有碎片性、扩散性、隐蔽性和多重性等特征。根据风险治理理论,当前中国药品监管体系存在部门职权单一、分散化属地管理、个体风险漠视和"运动式"应急等问题。要从根本上提升药品安全监管绩效,有必要利用本轮体制改革和修订《药品管理法》契机,重构药品管理体系的顶层设计。创新药品安全风险分析框架,设立高层次议事协调机构,完善属地化监管体制,并充分调动各利益相关方积极性,最终形成药品风险社会共治的新格局。

Fragmentation, diffusion, concealment and diversification compose of modern drug safety risk features. From the perspective of risk governance theory, there exist some defects within drug regulatory system, including single institutional function, decentralized administration, individual risk ignorance and ＂campaign-style＂ emergency management. To improve the performance of drug regulation and reconstruct the top design of drug regulatory system, it is necessary to take advantage of this round of administrative reform and the ＂Drug Administration Law＂ revision. Policy suggestions of a new paradigm of drug safety risk governance system are followed： innovate drug safety risk analysis framework, establish a high-level drug administration coordinating body, improve local regulatory system, and mobilize the involvement of stakeholders.