The value of a structured, systematic approach to benefit-risk assessment of medicines – SAHPRA case study

This study investigates the utility of the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework within the South African Health Products Regulatory Authority (SAHPRA) to determine whether adopting a structured approach improves consistency, transparency, and quality in benefit-risk assessments of new chemical entities (NCEs). The UMBRA eight-step framework was applied retrospectively and prospectively to six NCEs to systematically document the decision context, identify benefits and risks, and interpret the benefit-risk balance. Comparisons were made between initial SAHPRA narrative assessments and structured UMBRA-based evaluations.