HORIZON-JU-IHI-2024-08-03-two-stage: Modelling regulatory sandbox mechanisms and enabling their deployment to support breakthrough innovation

The action under this topic is expected to achieve the following impacts:

• Meaningful contributions to the successful implementation of regulatory sandboxes through developing a comprehensive and shared understanding of their use and value among key stakeholders in the healthcare ecosystem;
• Support the future-proofing of the EU regulatory framework by design, enabling the efficient implementation of regulatory sandboxes where and when appropriate, and thus helping to make Europe more attractive as place of innovation;
• Enhancing and enabling the cooperation of key healthcare stakeholders, including patients, clinicians, small and medium-sized enterprises (SMEs) and academics, with regulators in developing a competitive and innovation-friendly landscape;
• Fostering interaction with regulators to develop healthcare solutions when it is not possible to develop them within the current framework.

The action will also contribute to a number of European policies/initiatives, which include:

• the European Commission's Pharmaceutical Strategy for Europe, specifically the pillar on competitiveness, innovation and sustainability;
• related measures under the ongoing revision of the Pharmaceutical legislation;
• the European Commission innovation agenda (published in 2022) flagship initiative "Enabling innovation through experimentation spaces and public procurement" facilitating innovation through improved framework conditions including experimental approaches to regulation (e.g. regulatory sandboxes);
• the EU biotech strategy;
• the green and sustainability agenda.

The action under this