Global Development Programme Research
A documentation system was developed in support of CIRS Universal Methodology for Benefit Risk Assessment (UMBRA), an overarching framework that provides a platform for the coordinated development of benefit-risk assessment methodologies. The Summary portion of this system, which consists of the Benefit-Risk Template and User Manual (downloads below), has recently been evaluated in the CIRS International Summary Approach to Benefit Risk Evaluation (iSABRE) feasibility and pilot studies by regulatory agencies in China, Indonesia, Malaysia, Philippines and Chinese Taipei. Participants rated the Benefit-Risk Summary Template as good to excellent in navigation, clarity of instructions and applicability and comprehensiveness of guidance. They additionally indicated that the template has advantages of the systems currently in use in their organisation, contributes to achieving consistency of decisions between regulatory agencies and promotes effective communication to stakeholders.
For regulatory agencies in maturing markets, the use of the UMBRA Benefit-Risk Summary Template may afford an understanding of the reference agency benefit-risk evaluation and the ways in which it maps to the overarching framework, while providing a structured approach for reaching a local decision regarding the benefit-risk profile of new medicines.