Pharmacovigilance Principles: The Building Blocks of Benefit-Risk Assessments

Abstract

A medicinal product must demonstrate a favorable benefit-risk balance to remain on the market. That the benefits of use outweigh the risks is established using analyses referred to as benefit-risk assessments, which are conducted on an ongoing basis throughout the lifecycle of a medicinal product. While fundamental to maintaining a product’s marketing authorization, few regulatory guidance documents have been developed to provide information on the specific content and structure of a benefit-risk assessment. This paper aims to provide an overview of the key concepts in pharmacovigilance that contribute to the creation of a structured benefit-risk assessment, particularly through qualitative analysis.