Regulatory science to support translational development of patient-centred health technologies
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2026-01-IND-03
- Programme
- Cluster 1 - Health (Single stage - 2026)
- Programme Period
- 2021 - 2027
- Status
- Forthcoming (31094501)
- Opening Date
- February 10, 2026
- Deadline
- April 16, 2026
- Deadline Model
- single-stage
- Budget
- €9,800,000
- Min Grant Amount
- €3,000,000
- Max Grant Amount
- €4,000,000
- Expected Number of Grants
- 3
- Keywords
- HORIZON-HLTH-2026-01-IND-03HORIZON-HLTH-2026-01Clinical managementClinical trialsCohort studiesComparative effectiveness researchHealth dataHealth services, health care researchMeta-analysisQuality of health careRegistriesRisk assessmentSurveillance
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to several of the following expected outcomes:
- Policymakers and regulators will get accelerated access to improved evidence driven methodologies to evaluate the impact and efficiency of novel health technologies, facilitating decision-making for their use in humans and uptake in clinical practice.
- Patients and the health systems will benefit from the more targeted and efficient uptake of safe and effective health innovations in clinical practice, supporting more personalised approaches and improved care and public health.
The development, uptake and impact of health technologies typically results from a long product development process that is based on a 'life cycle approach' which typically involves several iterations of defined stages, i.e. from development, assessment to post-market surveillance and post-market clinical follow-up.
While health technologies are governed by comprehensive legal frameworks aiming to ensure that health technologies are safe and effective, the regulatory science underlying these legal frameworks needs to be updated. This concerns inter alia i) more precise delineation of specific requirements (e.g. closing existing gaps concerning sufficiency of clinical evidence) and ii) the consideration of novel biomedical approaches, data and digital solutions (e.g. artificial intelligence - AI, virtual human twin, new approach methodologies as well as methods that cut through these domains) which model and predict relevant biological parameters and exploit relevant end-points and novel (bio)markers for clinical diagnostic and prognostic predictions. Such update of the regulatory science of health technologies should aim at supporting an effective adoption and uptake into routine use by health systems and end-users (healthcare providers, citizens), while maintaining guardrails to ensure that innovative health technologies are backed up by evidence of sufficient quality and relevance to the human situation.
Proposals can cover all types of health technologies, aiming to define improved and novel sources of evidence with proven relevance for regulatory decision-making with a focus on safety and performance throughout their lifecycle, i.e. throughout the continuous process of clinical evaluation. To this end, proposals should address either, or a combination of the following: i) the improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment and ii) explore and examine to which extent novel information sources as indicated above can be considered as evidence that is satisfactory in view of regulatory needs concerning safety and performance.
Proposals should support the update and refinement of regulatory science on health technologies and contribute actionable information that can be used for improved or novel regulatory policies, rules, guidance documents and other tools with a view to ensuring that European patients and healthcare professionals have access to safe and effective innovative health technologies. Proposals should ultimately contribute to a regulatory environment that makes use of the full spectrum of novel biomedical and bio-digital approaches for clinical investigation and evaluation, while promoting a patient-centred approach to health technology innovation, facilitating the timely entry to market of performant and effective innovations and support their uptake in the health systems and clinical workflows without compromising patient safety.
Applicant consortia should reflect a broad representation of stakeholders, notably clinical societies, academia, notified bodies, industry, patients and regulators and the proposed work should address one or more of the following elements:
- Data and analyses on how existing approaches in regulatory science can be refined and improved in view of closing existing gaps of clarity, sufficiency of clinical evidence, generated on the basis of clinical studies and clinical investigations.
- Data and analyses on whether and to which extent novel information sources from biomedicine including new approach methods and digital and AI-enabled models and approaches can contribute to the clinical evaluation of innovative health technologies, e.g.:
- By providing information on relevant biophysical, anatomical, physiological and other disease-relevant aspects.
- By supporting information integration through the use and aggregation of already existing data, including clinical ones, from similar types or groups of technologies (e.g. retrospective information in registries, data collections, including Real-World Data (RWD)[1] from using technologies that have characteristics that are relevant for innovative technologies).
- By supporting improved planning and design of first-in-man clinical studies, with a view of enhancing the effectiveness and the safety of such studies and rationalising the use of resources of all involved actors by focusing the generation and assessment of clinical data on health technologies for which those data are indispensable.
- Data and analyses that examine to which extent the above-mentioned points can support the development and uptake of innovative technologies for unmet medical needs and for special patient populations (e.g. paediatric and rare conditions) via dedicated regulatory pathways and/or within a structured framework enabling their development and testing in a real-world environment under regulatory supervision (“regulatory sandbox”).
The actual conduct of clinical studies[2] is not in scope of this topic.
The activities should cover and draw on all the relevant healthcare innovation related frameworks other than pharmaceutical products, i.e. medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO).
The starting point is a good understanding of the innovative technology and of its inherent risks, so that appropriate safety and quality requirements can be applied for monitoring the outcome in the relevant healthcare setting. As the number of hybrid or combinations of health technologies increases and technology integration becomes rather the norm than an exception in health innovation, the current segregated, technology-specific, frameworks may not provide a clear path forward for the health technology that is targeted. To that end, when considering an innovation, it is important to consider all relevant legislative frameworks including MDR[3] and IVDR[4], the proposed SoHO-Regulation[5], and AI Act[6] among others.
Proposals are encouraged to consider, where relevant, the data, expertise and services offered by European research infrastructures especially those active in the health domain, such as EATRIS ERIC[7], and also the findings of previous EU-projects (e.g.: CORE-MD[8]).
[1] EMA definition: “Real-World Data are routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials (e.g. claims databases, hospital data, electronic health records, registries, mhealth data, etc.)”.
[2] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
[3] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices: https://eur-lex.europa.eu/eli/reg/2017/745/oj
[4] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices: https://eur-lex.europa.eu/eli/reg/2017/746/oj
[5] Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application: https://eur-lex.europa.eu/eli/reg/2024/1938/oj
[6] https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai, https://eur-lex.europa.eu/eli/reg/2024/1689/oj
[7] European Infrastructure for Translational Medicine: https://www.eatris.eu
[8] Improved methods for clinical investigation and evaluation of high-risk medical devices: https://www.core-md.eu
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027[1]. In addition, Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 1 “The Green Transition” are supported.
Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “the EU health industry is innovative, sustainable, and globally competitive thanks to improved uptake of breakthrough technologies and innovations (including social innovations) that make the EU with its Member States and Associated Countries more resilient and less reliant on imports of critical health technologies”.
The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of healthcare services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for Research and Innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).
In line with the Commission's Political Guidelines for 2024-2029[2], and building on the recommendations of the reports by Mario Draghi[3] and Enrico Letta[4], as well as the “Strategy for European Life Sciences”[5], this destination will support research and innovation to enhance the competitiveness of the European health industry, thereby reinforcing EU autonomy, consolidating its Single Market, and empowering Europe to effectively address the burden of both communicable and non-communicable diseases. In this Work Programme part, Destination “Maintaining an innovative, sustainable, and competitive EU health industry” focuses on collaborative efforts to advance cell-free protein synthesis platforms, ready-to-use point-of-care diagnostics, and regulatory science to support translational development of patient-centred health technologies. The results will support the EU Industrial Policy, with a focus on strengthening the resilience of the single market, addressing the EU’s strategic dependencies, gaining technological sovereignty and accelerating the green and digital transitions. The results will further strengthen the single market, by providing evidence and guidelines for stakeholders and regulators to ensure adoption of innovations, supporting environmental, fiscal and socio-economic sustainability and at the same time fostering healthcare access and reducing health inequities. The results will also support the implementation of the relevant Regulations like those on Medical Devices (MDR) and In-Vitro Medical Devices (IVDR) as well as the general uptake of innovative health technologies by health systems, with a special view to aspects related to ensuring industry competitiveness, fostering innovation and sustainability, while maintaining the high level of quality, safety and efficacy of these health technologies.
In view of increasing the impact of EU investments under Horizon Europe, the Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, development and adoption of best practices, or joint communication activities. All topics are open to international collaboration to address global environment and health challenges.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and competitive EU health industry, and more specifically to one or several of the following expected impacts:
- Health industry in Europe and Associated Countries is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and (digital) technologies, contributing to job creation and economic growth, in particular with small and medium-sized enterprises (SMEs)[6].
- Health industry is supported by cross-sectoral Research and Innovation in the context of convergence of health technologies (integrating medical technologies, pharmaceuticals, biotechnologies, digital health, and e-health technologies) while strengthening key market positions.
- Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, healthcare providers, health authorities and regulators ensuring suitability and acceptance of solutions.
- Citizens, healthcare providers and health systems benefit from a swift uptake of innovative health technologies and services through the provision of evidence and guidelines for stakeholders, policymakers and regulators. These efforts offer significant improvements in health outcomes, also potentially strengthening access to healthcare for all and reducing health inequities while health industry benefits from decreased time-to-market.
- Citizens, healthcare providers and health systems benefit from increased health security in Europe and Associated Countries due to reliable access to key manufacturing capacity, including timely provision of essential medical supplies and technologies of particularly complex or critical supply and distribution chains.
Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme.
The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers[7] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[2] https://commission.europa.eu/about/commission-2024-2029_en
[3] The future of European competitiveness, Mario Draghi: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en
[4] Much more than a market, Enrico Letta: https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf
[5] https://research-and-innovation.ec.europa.eu/strategy/strategy-research-and-innovation/jobs-and-economy/towards-strategy-european-life-sciences_en; https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686
[6] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[7] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).
Eligibility & Conditions
General conditions
1. Admissibility Conditions, proposal page limit and layout
2. Eligible Countries
Eligible countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
3. Other Eligibility Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Subject to restrictions for the protection of European communication networks.
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
Application and evaluation form templates
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Additional documents
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 4. Health
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
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