国外药品效益风险评价研究进展

Overview of Drug Benefit-Risk Assessment Research Progress

药品的效益风险评价是保证药品安全性的重要手段,因此建立科学、综合、统一的评价方法和框架尤为重要。本文从监管机构、行业组织以及企业3个角度,分别阐述国外药品效益风险评价的热点问题与研究进展。同时结合我国研究现状,对国内药品效益风险评价提出建议。

Benefit-risk assessment is an important means of ensuring drug safety, so it is particularly important to establish scientific, comprehensive and unified evaluation method and framework. In order to understand the foreign research situation of drug benefit-risk assessment, this article describes the hot topics and research progress among agencies, industry organizations, as well as enterprise, and further research areas. Moreover, based on the present situation of our drugs benefit-risk assessment. regulatory summerises the challenges and prospects of current country, the article provides reference for domestic