Regulatory sandboxes are emerging as a powerful tool to accelerate innovation in healthcare, and their potential in the rare disease space is especially promising as they offer flexible, structured environments where novel approaches to regulation can be safely tested and refined.
This topic was part of the special session at the IRDiRC Consortium Assembly and Scientific Committees meeting in Brussels (2025), highlighting the urgency and opportunity to rethink regulation for rare diseases at a global scale.
Read the full publication, available open access at the following link: https://www.sciencedirect.com/science/article/pii/S2950008725000547?via%3Dihub