Deadline Date: April 16, 2026
The European Commission is seeking applications to support regulatory science that advances the development and uptake of patient-centred health technologies across the European Union.
The focus of this opportunity is on enabling improved evidence-driven methodologies for evaluating the impact and efficiency of novel health technologies, facilitating better decision-making by policymakers and regulators, and supporting the targeted and efficient uptake of safe and effective innovations in clinical practice, thereby advancing personalised healthcare and improving public health outcomes.
The development and implementation of health technologies follow a life cycle approach that includes stages from initial development and assessment to post-market surveillance and clinical follow-up. While robust legal frameworks already exist to ensure safety and effectiveness, there is a clear need to update the regulatory science that underpins these frameworks. This includes refining specific requirements, particularly regarding the sufficiency of clinical evidence, and integrating novel biomedical approaches and digital solutions such as artificial intelligence, virtual human twins, and new methodologies capable of modelling and predicting biological parameters.
Proposals under this initiative are expected to explore improved and novel sources of evidence relevant to regulatory decision-making, with a strong emphasis on safety and performance throughout the entire lifecycle of health technologies. This may involve enhancing existing methodologies to better suit specific types or classes of technologies, as well as examining how emerging data sources and innovative approaches can meet regulatory standards for evidence.
A key aim is to generate actionable outcomes that contribute to updated regulatory policies, guidance documents, and tools, ensuring that innovative health technologies can be efficiently evaluated and adopted without compromising patient safety. By fostering the integration of advanced biomedical and digital approaches into clinical investigation and evaluation, the initiative supports a regulatory environment that promotes timely market entry and effective uptake of innovations within healthcare systems.
The total budget allocated for this topic is €19.6 million, with individual project funding ranging between €4 million and €6 million. Participation is open to any legal entity worldwide, provided that the eligibility conditions under the Horizon Europe framework are met. Applicants must register in the Participant Register and obtain a Participant Identification Code (PIC) as part of the application process.
For more information, visit European Commission.
