Pilot Actions For Follow-on Funding: Leveraging Eu-funded Collaborative Research In Regenerative Medicine
HORIZON Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2026-01-TOOL-05
- 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-TOOL-05HORIZON-HLTH-2026-01AllergyGene therapy, cell therapy, regenerative medicineHealth-related biotechnologyMedical biotechnology
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:
- The overall competitiveness of the EU biotechnology sector is strengthened through the further development of closer-to-deployment health innovations.
- The EU benefits from greater impact of the EU’s Research and Innovation (R&I) Framework Programmes through successful leveraging of previous EU funding in the field of regenerative medicine.
- EU innovators secure further funding to finalise the last stages of development.
- Patients benefit faster from solutions that improve their health and wellbeing.
R&I is essential for economic growth and boosting the competitiveness of the EU's life sciences sector. Through the Horizon 2020 and Horizon Europe Framework Programmes, the EU has supported projects that significantly impact our health by fostering scientific discoveries and developing new solutions. Transformational health innovations, such as mRNA vaccines, highlight the importance of collaboration among businesses, research institutions, and healthcare providers. Furthermore, sustained funding throughout the entire value chain is crucial for maximising impact and ensuring more products reach patients faster. The main aim of this topic is to pilot a follow-on funding mechanism, supporting the stepwise development of biotech innovations through collaboration, resulting from previously supported EU R&I actions in the field of health. This topic contributes to strengthening the R&I ecosystem within the EU and supports the implementation of the “Strategy for European Life Sciences”[1]. Given the importance of biotechnology as a critical technology[2], this topic aims to ensure that promising research results are efficiently taken further along the value chain, speeding the time to market or patient through stepwise funding and increasing the EU’s competitiveness. The chosen area of focus is regenerative medicine as it has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to normalise congenital defects. Proposals should focus on prototyping, demonstrating and validating health innovations from TRL 5, moving beyond early-stage research to clinical development, testing, or eventual large-scale manufacturing. The previously funded EU research on which the proposal is build should be applicable to the field of regenerative medicine and should have clear exploitation potential and/or socio-economic benefits for the patients.
Applicants are expected to:
- Demonstrate in their proposal that the health product, therapy or service, has been successfully validated at preclinical level in the prior EU funded project and provide justification of the innovation potential with qualitative and quantitative data (e.g. publications, patent/trademark/design applications, spin-out/start-up track record, regulatory procedures, venture capital pitches, funds raised etc).
- Justify the proposed composition of the consortium and explain how this differs from the previous grant, and demonstrate how the health product, therapy or service to be developed further qualifies as regenerative medicine.
- Demonstrate adequate protection of the idea or Intellectual Property Rights or ensure freedom to operate until full deployment.
- Have a clear vision on the intended pathway to patients and/or route to market, including regulatory compliance. This includes defining specific milestones together with concrete and verifiable Key Performance Indicators (KPIs) to assess progress towards the market or healthcare settings.
- Identify the target patient group(s) (how many patients to be treated during the project and the potential patient population that could benefit) and product development milestones including a financial plan (for each milestone).
In the case of innovations with commercial potential, proposals should present the investor and market readiness towards commercialisation and deployment (market research, value proposition, business case and business model, prospects for growth, intellectual property protection, competitor analysis etc.) as well as aspects of regulation, certification and standardisation and reimbursement.
In the case of innovations with evidenced limited commercial potential but high patient benefit, proposals should contain a deployment and sustainability plan including aspects related to regulations, certification and standardisation and patient access through healthcare providers.
Proposals should take into account sex, gender, age and other relevant socio-demographic variables to ensure the scientific robustness, clinical value and applicability of the targeted regenerative medicine innovation.
Applicants should provide details of their clinical studies[3] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] 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
[2] Commission Recommendation on critical technology areas for the EU's economic security for further risk assessment with Member States: https://defence-industry-space.ec.europa.eu/system/files/2023-10/C_2023_6689_1_EN_annexe_acte_autonome_part1_v9.pdf
[3] 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.
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 3 “A More Resilient, Competitive, Inclusive, and Democratic Europe” of Horizon Europe’s strategic plan 2025-2027[1].
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: “Health technologies, data, new tools, and digital solutions are applied effectively thanks to their inclusive, ethically sound, secure and sustainable delivery, integration and deployment in health policies and in health and care systems.”
The Health Cluster will continue to drive the development and adoption of innovative technologies and digital solutions to improve healthcare and health systems. This will ensure that the EU remains at the forefront of breakthrough health and medical technologies and can achieve open strategic autonomy in essential medical supplies and digital innovations.
In line with the Commission's Political Guidelines for 2024-2029[2], this destination will support research and innovation in tools and technologies strengthening the competitiveness of European health industry and reinforcing EU autonomy. This effort will contribute to the completion of the European Health Union which aims to enhance the resilience of healthcare systems, facilitate access to innovative and affordable healthcare solutions, and ensure that all citizens have access to high-quality, equitable, inclusive and sustainable healthcare.
The development and use of innovative tools and technologies for biomedical research are the basis for prevention, early diagnosis, efficacious therapy and patient monitoring, essential components of efficient healthcare. These include enabling technologies, not least innovative biotechnological approaches, and emerging technologies like synthetic biology, digital tools including those based on Machine-Learning/Artificial Intelligence (ML/AI) and other data-driven approaches which will enable the development of more personalised medicine. Hence the combination of innovative tools, high-quality health data (incl. Real-World Data - RWD[3]), digital technologies, modelling and AI tools holds great potential not only for advancing biomedical Research and Innovation but for developing health technologies that improve healthcare.
However, the implementation of these tools and technologies faces specific barriers such as scalability, regulatory frameworks and public acceptance and trust. To overcome these challenges cross-sectoral cooperation among stakeholders including researchers, regulatory bodies, policymakers, industry, healthcare providers and patients, is necessary. This collaboration will facilitate the design and development of innovative health products and services, tailored to specific population groups, ultimately improving patient outcomes and reducing health inequalities.
By taking a comprehensive and inclusive approach, this destination will prioritise the development of novel tools and technologies that address key considerations such as the rights of the individual, safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability while also ensuring ethical, legal and regulatory compliance.
In this Work Programme part, Destination “Developing and using new tools, technologies and digital solutions for a healthy society” is driven mainly by three key Commission policies, the “Biotechnology and Biomanufacturing Communication”[4] the “Artificial Intelligence Strategy”[5] and the “Strategy for European Life Sciences”[6] and focuses on developing and applying innovative technologies to improve human health and healthcare systems. The topics under this destination cover efforts to develop AI based predictive biomarkers for disease prognosis and treatment response, advancing bio-printing of living cells for regenerative medicine, and integrating New Approach Methodologies (NAMs) to advance biomedical research, as well as developing virtual human twins for integrated clinical decision support.
To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. For example, this cooperation could take the form of networking, to joint activities, such as the participation in joint workshops, exchange of knowledge, development and adoption of best practices, or joint communication activities. Opportunities for such activities and potential synergies exist between projects funded under the same topic but also between other projects funded under different topics, Clusters or Pillars of Horizon Europe. Specifically, this could involve projects related to European health research infrastructures (under Pillar I of Horizon Europe), the EIC[7] strategic challenges on health (under Pillar III of Horizon Europe) or with projects on themes that cut across the Clusters of Pillar II such as with Cluster “Digital, Industry and Space” on digitalisation of the health sector or key enabling technologies.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway towards the development and use of new tools, technologies and digital solutions for a healthy society, and more specifically to one or several of the following impacts:
- Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in healthcare is world-class.
- Citizens benefit from targeted and faster research resulting in safer, more sustainable, efficient, cost-effective, accessible and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and wellbeing, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation)[8].
- The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
- The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for healthcare.
- Both the productivity of health Research and Innovation, and the quality and outcome of healthcare is improved thanks to the use of health data and innovative analytical tools, such as AI supported decision-making, in a secure, ethical and inclusive manner, respecting individual integrity and underpinned with public acceptance and trust.
- Citizens trust and support the opportunities offered by innovative technologies for healthcare, based on expected health outcomes and potential risks involved.
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[9] 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] 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.)”.
[4] Commission Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; COM(2024) 137 final: https://research-and-innovation.ec.europa.eu/document/download/47554adc-dffc-411b-8cd6-b52417514cb3_en
[5] Commission Communication on Artificial Intelligence for Europe; COM(2018) 237 final: https://digital-strategy.ec.europa.eu/en/policies/european-approach-artificial-intelligence; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:237:FIN
[6] 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
[8] Commission Communication on the digital transformation of health and care; COM(2018) 233 final
[9] 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
The proposals must be based on results generated within a prior multi-beneficiary project funded under Horizon 2020 or Horizon Europe Framework Programme. This project must have been completed maximum 3 years before the submission deadline.
Applicants must explicitly state in their proposal the prior multi-beneficiary project concerned. Projects funded under Marie Sklodowska-Curie Actions are not considered eligible. Projects funded under co-funded European Partnerships or ERANETs are considered eligible. Ongoing projects[[Projects that have not been completed before the submission deadline.]] are not considered eligible.
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).
In line with the “restriction on control in innovation actions in critical technology areas” delineated in General Annex B of the General Annexes, entities established in an eligible country but which are directly or indirectly controlled by China or by a legal entity established in China are not eligible to participate in the action.
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
Information on clinical studies (HE)
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
Frequently Asked Questions About Pilot Actions For Follow-on Funding: Leveraging Eu-funded Collaborative Research In Regenerative Medicine
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search help you find a partner organisation for your proposal.
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