[关键词]
[摘要]
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,而我国的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。本文基于全球的视角,对上市后药品安全主动监测系统的发展进行概述,并从不同的国家和地区选取5个最具有代表性的系统进行深入的比较、分析与评价,在此基础之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。
[Key word]
[Abstract]
Active post-marketing drug safety surveillance is an important mean 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 comparison, analysis and evaluation, and put forward some enlightenments for the construction of the active post-marketing drug safety surveillance system in China.
[中图分类号]
R95
[基金项目]
国家社会科学基金项目“基于实证的TRIPS框架下中国药品试验数据保护制度研究”(13CFX086);辽宁省教育厅科学研究一般项目“辽宁省药品安全监管机制创新研究”(W2014119);沈阳药科大学中青年教师事业发展支持计划“药品可及性视角下的我国罕用药研发激励政策研究”(2014-B2)