全球视角下上市后药品安全主动监测系统比较研究及启示

Comparative Research and Enlightenment on Active Post-marketing Drug Safety Surveillance Systems from the Global Perspective

开展上市后药品安全主动监测是维护公共健康的重要手段,世界上很多国家和地区都在积极建设和发展上市后药品安全主动监测系统,而我国上市后药品安全主动监测系统的建设还处于探索和起步阶段。文章基于全球的视角对上市后药品安全主动监测系统的发展进行概述,并从不同国家和地区选取5个最具有代表性的系统进行深入比较、分析与评价,在此基础上得出建设我国上市后药品安全主动监测系统的一些启示。

Active post-marketing drug safety surveillance is an important means to protect public health. Many countries and regions in the world are actively building and developing the active post-marketing drug safety surveillance systems, but the construction of active post-marketing drug safety surveillance system in China is still in the initial stage. Based on the global perspective, this paper summarized the development of active post-marketing drug safety surveillance systems in the world, selected 5 most representative systems from different countries and regions to make in-depth comparisons, analysis and evaluations, and put forward some enlightenments for the construction of the active post-marketing drug safety surveillance system in China.