New IRDiRC Publication - Regulatory sandboxes: A new frontier for rare disease therapies
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.
A regulatory sandbox is a controlled regulatory environment that allows innovators to experiment with novel products, services, and business models under regulatory supervision [5]. This framework is designed to facilitate the testing of innovations while ensuring compliance with regulatory requirements. Regulatory sandboxes operate within a controlled environment where innovations are tested under predefined rules and conditions. They are temporary by nature, meaning participation is time-limited and designed with clear objectives. One of their most significant advantages is the regulatory flexibility they offer, allowing deviations from standard regulatory pathways to accommodate novel approaches which would not fit in any of the existing frameworks.
Read the full publication now: https://lnkd.in/eGTVHfmY