Abstract: 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 regulatory agencies, industry organizations, as well as enterprise, and further summerises the challenges and prospects of current research areas. Moreover, based on the present situation of our country, the article provides reference for domestic drugs benefit-risk assessment.

Key words: drugs, benefit, risk, assessment