Breakthrough Regulatory Innovation and Development throuGh sandbox Environments
BRIDGE is reshaping the future of health regulation in Europe. Bringing together regulators, researchers, industry and patient representatives, the project is developing a framework for “regulatory sandboxes” – safe, real-world test environments for innovative health technologies. This enables new digital solutions and advanced therapies to reach patients faster, more safely and with stronger evidence – to the benefit of people and health systems across Europe.
BRIDGE equips Europe with a comprehensive framework to develop and assess emerging health technologies safely and efficiently. Through collaborative effort, we can align regulatory processes with innovation and deliver promising solutions to patients faster.
Gökhan Ertaylan, BRIDGE coordinator,
VITO Flemish Institute for Technological Research
For industry, early regulatory alignment is essential. BRIDGE will help reduce uncertainty and support faster, responsible development of breakthrough therapies and technologies.
Geert Preuveneers, BRIDGE industry co-lead,
MSD Regulatory Affairs Europe
This pre-competitive regulatory science project is unique. BRIDGE is about increasing the readiness of Europe to make use of effective regulatory sandboxes for innovative healthcare technologies and methodologies development.
Francois Hebraud, BRIDGE industry co-lead,
ROCHE EU Regulatory Policy Lead
November 2025 – October 2028
(36 months)
Innovative Health Initiative (IHI)
Joint Undertaking via Public-Private Partnership
€9,355,434.25,
of which €5,199,814.25
requested EU contribution
VITO (Belgium)
MSD and ROCHE
The BRIDGE consortium met for its General Assembly and Consortium Meeting in Dijon, France, from 22 to 24 April 2026. Partners came together over three days to review progress, exchange [...]
The updated Council text on the General Pharmaceutical Legislation marks an important step in the development of regulatory sandboxes in the EU. By setting out a mechanism for innovative medicinal [...]
The presentation in December 2025 of a new EU Health Package, including the proposed European Biotech Act and revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation [...]
