Benefit-risk balance (or effectiveness/risk)

An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks (quality, safety, or efficacy) of the medicinal product for the patients’ or public health.

Pharmacovigilance activities and PSURs / DSURs help to continuously evaluate this balance, and quantitatively assess the merit of a medicinal product comparatively to other therapies – using more comprehensive data than pre-marketing information that is based on a limited number of selected patients.