19 December 2025 - The evaluation of early access requests for medicines inherently involves a degree of uncertainty. Indeed, it relies primarily on assessing the presumption of innovation rather than demonstrating that innovation.

To define the minimum data required to confirm or refute the additional clinical benefit of the treatment compared to available alternatives, and thus limit the risk to patients, the French National Authority for Health is updating its evaluation guidelines.

Read Haute Autorité de Santé press release [French]