The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory Authorities

Background: In 2008, a consortium of 4 regulatory authorities, the Australian Therapeutic Goods Administration (TGA), Health Canada, Swissmedic, and Singapore Health Sciences Authority (HSA) approached the Centre for Innovation in Regulatory Science (CIRS) to support the development of a benefit-risk framework and template that could be used by all 4 authorities and that would enable joint and shared reviews to maximize resources. CIRS facilitated this collaboration, the Consortium on Benefit-Risk Assessment (COBRA), between 2008 and 2013.

Methods: COBRA developed a benefit-risk assessment template based on the EMA reflection paper of 2008, which was constructed and then evaluated in 3 phases: a feasibility study, a retrospective pilot study, and a prospective study. The final template corresponded to the Universal Methodology for Benefit-Risk Assessment (UMBRA) developed by CIRS.

Results: By 2014, elements of the template, which had been developed during the program of work, aided the authorities in documenting the benefit-risk assessment of medicines in a systematic and structured way. However, its role in the individual authority's assessment toolkit was influenced by the number of key elements within the template that were already included in their current clinical assessment templates. Notably, the agencies indicated that they will modify their clinical assessment templates to align with the UMBRA 8-step framework approach.

Conclusions: Overall, the authorities believed that the project had given them a better understanding of the value of using a structured approach to the benefit-risk assessment of medicines as well as enabling shared learnings between the authorities.