The arguments for streamlining and speeding up regulatory approval processes for new therapies are well-rehearsed.1 Removing delays facilitates earlier access to new, potentially life-changing medicines for patients who may have few other therapeutic options. In addition, shorter and more specific licensing processes may better support the development of new medicines for small numbers of patients who may have very rare conditions. Nevertheless, at its core, licensing of a medicine involves assessment of data on its quality, safety and efficacy and requires a judgement of the overall risk–benefit balance. The earlier …