An evaluation of the use of the Universal Benefit-Risk Assessment Framework by the Zambia Medicines Regulatory Authority for documenting and communicating benefit-risk decisions.

Abstract

Transparent and consistent medicines approval processes support stakeholder trust in National Medicines Regulatory Authorities (NMRAs). Structured benefit-risk assessment frameworks may strengthen such transparency and consistency. One example is the Universal Methodology for Benefit-Risk Assessment (UMBRA) developed by the Centre for Innovation in Regulatory Science in collaboration with four regulatory authorities. This study evaluated the feasibility, usability and perceived value of applying UMBRA within the Zambia Medicines Regulatory Authority (ZAMRA) and compared the explicitness and structure of UMBRA benefit-risk documentation with the existing narrative approach. In this exploratory comparative case study, two ZAMRA assessors applied UMBRA retrospectively to two previously reviewed applications and prospectively, alongside routine assessment, to two applications. Documentary comparison and directed content analysis of assessor feedback were conducted. Across the four cases, UMBRA made the decision context, selected benefits and risks, their relative importance, uncertainties and the basis for the benefit-risk conclusion more explicit than narrative assessments. Both assessors found the template useable and considered its structured format potentially valuable for reviewer training and implementation. One assessor initially required clarification on recording adverse events. These findings represent four cases and two assessors' perceptions and do not establish improvements in decision quality, inter-assessor consistency, review time or regulatory outcomes.