美国药品安全体系改革的善治化趋势及其启示

Introduction to Good Governance in US Drug Safety System Reform and its Enlightenment

近年来，“万络”等药品安全事件促使美国采取一系列措施以完善其药品安全体系，而美国这一系列改革实施的过程充分体现了当今公共管理领域的善治化趋势。本文在介绍和分析美国改革的背景、原因以及相关行动的基础上，结合善治的特征对美国改革经验进行总结，以期为我国药品安全工作的深入提供一定的借鉴。

The United States has adopted a series of measures to improve its drug safety system because of rofecoxib safety problem. The reforming process has fully reflected the trend of Good Governance in the filed of current public management. This paper analyzes the background, causes and procedures of US reform, and also sums up the experience of this reform combining with the characteristics of Good Governance, which could provide some insight for the improvement of China＇s drug supervision system.