Regulatory sandboxes: Bridging the gap between health innovation and regulatory pace

Regulatory sandboxes: Bridging the gap between health innovation and regulatory pace

Gökhan Ertaylan, François Hebraud, and Geert Preuveneers, representing the BRIDGE consortium, focus here on regulatory sandboxes to bridge the gap between health innovation and regulatory pace. Healthcare innovation in Europe is advancing faster than the regulatory frameworks designed to govern it. To ensure these breakthroughs remain safe, effective, and aligned with societal values, Europe must embrace new mechanisms that bridge emerging regulatory gaps without overburdening innovators or regulators. We believe regulatory sandboxes are central to this mission. Through the Innovative Health Initiative (IHI) BRIDGE project, a robust public-private partnership, we are defining, designing, and validating how regulatory sandboxes can transform the European healthcare ecosystem into an adaptive and sustainable model.