BRIDGE contributed to a joint European Commission (EC) and European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandboxes, held on 21 September 2026. The workshop brought together stakeholders to discuss how regulatory sandboxes foreseen under the revised EU pharmaceutical legislation could be implemented and operated effectively in practice.
BRIDGE was invited to present the perspective of the IHI BRIDGE consortium alongside contributions from the European Commission and EMA. The presentation highlighted BRIDGE’s perspective on regulatory sandboxes and its work to translate the concept into practical approaches and processes that can support their implementation in healthcare. The workshop also included breakout discussions on horizon scanning, sandbox planning, and transparency and communication.
BRIDGE is developing practical recommendations and tools to support the full lifecycle of a regulatory sandbox, from identifying emerging innovations and assessing their suitability for participation, through sandbox design and operation, to transition out of the sandbox, evaluation and regulatory learning.
A key element of this work is MOSAIC – the Modular Operational Sandbox for Healthcare Innovation and Compliance – which is being developed as a modular framework for structuring and connecting the different stages and components of a regulatory sandbox. This is complemented by approaches and tools covering horizon scanning, readiness assessment, sandbox planning, information governance and end-to-end sandbox operation.
Participation in the EC–EMA workshop provided an important opportunity for BRIDGE to contribute its emerging work to the wider European discussion on how regulatory sandboxes can be implemented in practice, while also gathering insights to inform the project’s ongoing work. This reflects the project’s commitment to engaging with regulators, policymakers, innovators and other stakeholders as its approaches and tools are progressively developed, tested and refined.
The BRIDGE presentation, alongside presentations from the EC and EMA, the workshop agenda and the video recording, is publicly available on the EMA website.