Regulatory science to support translational development of patient-centred health technologies

The EU initiative “Regulatory Science to Support Translational Development of Patient-Centred Health Technologies” funds pioneering research and innovation projects aimed at updating regulatory science and methodological development in the field of patient-centred health technologies. The objective is to develop and validate improved sources of evidence covering the entire lifecycle of health innovations – from the preclinical phase to market-near evaluation. The initiative supports interdisciplinary consortia consisting of small and medium-sized enterprises (SMEs), industry-related research institutions, Notified Bodies, clinical professional societies, patient organizations, universities, and regulatory authorities. Eligible costs include personnel, material expenses, and subcontractors, with a funding rate of up to 100%. The project duration is 36 months, with funding amounts ranging between €4,000,000 and €6,000,000.

Consortia composed of at least three partners from different EU/associated countries that jointly present a methodologically sound roadmap for the translational development of safe and effective health technologies are eligible to participate in the call. Projects integrating, for example, AI-supported models, new biomarkers, or virtual patient models into regulatory assessment to enhance patient safety and accelerate market access will be funded. Submissions must be made electronically via the Funding & Tenders Portal; the deadline is 16 April 2026, 17:00 (Brussels time). By updating regulatory methodologies, the programme contributes to making the European health industry more resilient, innovative, and globally competitive.