AVAILABLE SOON. This report provides insights into the methods used to evaluate the benefit-risk (BR) balance of a medicinal product. A favourable BR profile must be established for all medicinal products prior to marketing. This balance must be reassessed periodically in the post-marketing setting when new information regarding the benefits and risks, or the landscape of their application, becomes available. This report builds on the foundations of the CIOMS Working Group IV report published in 1998, and entitled: BenefitRisk Balance for Marketed Drugs: Evaluating Safety Signals; and expands to BR management throughout a product’s lifecycle using structured approaches and updated methodologies.

This report reflects the consensus opinion of the CIOMS Working Group XII members, including experts in BR assessment drawn from academia, industry, and regulatory organisations. It was finalised after considering comments received during a public consultation.

The report is intended for medicinal product developers, regulatory authorities, and key stakeholders including academic and government researchers, healthcare professionals, and patients/consumers – all those interested in how the balance between the benefits and risks associated with a medicinal product is established and managed.

https://doi.org/10.56759/gwfz1791