BRIDGE Project launches to advance regulatory sandboxes for healthcare innovation

The EU-funded BRIDGE project (Breakthrough Regulatory Innovation and Development throuGh sandbox Environments) officially begins its mission to deliver a framework for regulatory sandboxes for emerging health technologies in Europe. The project, which is a flagship of the Innovative Health Initiative (IHI), recognises that cutting-edge health innovations often do not fit neatly within existing regulatory frameworks, delaying their development and patient access. Regulatory sandbox mechanisms offer a way forward through experimentation.

Regulatory sandbox mechanisms offer a way to address this challenge by allowing innovators and regulators to collaborate early, test new approaches, determine the most effective regulatory pathways for cutting-edge health technologies – supporting their development and smooth entry into the market.

The implementation of regulatory sandboxes in healthcare is still in its early stages. In Europe, it remains only a concept in the biomedical and biotherapeutics field. Translating a concept into an effective tool is the challenge BRIDGE aims to address.

BRIDGE will deliver comprehensive policy recommendations to embed sandbox approaches sustainably into the European regulatory ecosystem. These will be supported by:

• A proactive horizon-scanning approach to identify emerging technologies and methodologies that challenge current frameworks from fields of medicine, data, AI, in vitro diagnostics, medical devices, regenerative medicine, substances of human origin, gene editing, Internet of Medical Things, innovative clinical trials, new manufacturing approaches to name a few.
• Regulatory readiness and eligibility criteria for determining when sandboxing is appropriate.
• The MOSAIC architecture; An operational blueprint for designing and running regulatory sandboxes. It will function as a configurable set of modules (‘bricks’) than can be adapted to different types of health innovations.
• Case studies and simulations that test and refine the sandbox architecture in realistic scenarios.

Together, these outputs will support a more anticipatory, agile and adaptive regulatory environment for medical innovation across Europe.

The BRIDGE consortium consists of 28 organisations from 12 countries, of which 13 are public partners and 15 industry partners. These organisations include regulators, health technology assessment (HTA) bodies, research organisations, intergovernmental associations and multi-stakeholder associations at EU, member state (MS) and regional levels.

This balanced public-private partnerships brings together diverse perspectives essential for developing solutions that work across the healthcare ecosystem.

This groundbreaking public-private partnership positions us uniquely to advance our ambitious shared mission. At our recent kick-off meeting, representatives from all partner organisations came together for two days of presentations, strategic planning, and collaborative working sessions. Their diverse perspectives and expertise enriched the discussions, laying a strong foundation for our collective efforts moving forward.

Over the next three years, BRIDGE will develop Europe’s first comprehensive regulatory sandbox framework for health. In this process, BRIDGE aims to engage in dialogue with various stakeholders. Interested individuals and organisations are encouraged to subscribe to the project in order to be kept up to date on relevant engagement opportunities.

i~HD is responsible for developing the operating principles of the MOSAIC Sandbox and the detailed sandbox process design. It will develop and host a European repository of regulatory sandbox best practices, promoting sandbox governance and promoting their added value. i~HD is also responsible for the communications strategy and quality assurance processes.