Stuart Walker

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.

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 b...