Implementation of the Benefit–Risk Summary Template by a Maturing Agency: A Case Study

The assessment of benefits and risks of medicinal products for regulatory approval remains largely a qualitative exercise, although there are ongoing initiatives to introduce a quantitative approach into the review process. Given the current setting, it is important that both the processes and the benefit–risk decisions are transparent and communicated to stakeholders for accountability. Hence, there is a need to find appropriate tools to enhance communication in a manner that it would uphold transparency, consistency, and standards.