Establishing a European network of Centres of Excellence (CoEs) for Advanced Therapies Medicinal Products (ATMPs)
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2026-01-TOOL-07
- 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-07HORIZON-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:
- In line with the objectives of the “Strategy for European Life Sciences”[1], the EU successfully translates a strategic priority into an implementable action plan for building technological and innovation leadership on a global stage.
- Europe, including regions, profits from an increased capacity, accessibility, coordination of its Advanced Therapies Medicinal Products (ATMP) infrastructures.
- The European economy benefits from more ATMP innovations being developed and commercialised in the EU.
- Patients across the EU gain faster access to innovative ATMPs thanks to increased and focused public Research and Development (R&D) investment, harmonised policies and strategies for ATMP development and uptake in healthcare systems.
ATMPs represent a frontier in medicine, offering groundbreaking treatments such as gene therapies, cell therapies, and tissue-engineered products that hold the promise of addressing complex and previously untreatable conditions. The European ATMP landscape is dynamic and promising, with 28 products having received marketing authorisation and many more in the pipeline[2]. The development of specialised infrastructures in Europe for these cutting-edge therapies is crucial for fostering innovation and ensuring fast and efficient delivery to patients in an equitable way. The report by Mario Draghi[3] on EU competitiveness, highlights that the EU’s share of the fast-growing global ATMP market is small, suggesting that to remain competitive, increased and focused public R&D investment is needed to complement ongoing efforts to streamline regulations and ensure faster pricing and reimbursement. The report recommends building on existing innovation hubs and expanding the capacity of the EU to conduct ATMPs R&D by the consolidation of EU public funds. By strengthening this budding innovation ecosystem, Europe can position itself as a leader in the ATMP sector, ultimately improving patient access to life-saving treatments and stimulating economic growth.
The EU has several scattered ATMP centres with divergent capacities and capabilities[4], limiting its attractiveness for scaling up R&D in the field, calling for a coherent and coordinated approach. The aim of this topic is to establish a European network of Centres of Excellence (CoEs) for ATMPs, building on existing centres and coordinating their further development in synergy with national strategies. The creation of such a Network is key for strengthening the EU’s capacity to develop, scale up and deploy ATMPs across Europe, increasing Europe’s attractiveness for clinical research in the field and supporting the implementation of the “Strategy for European Life Sciences”. The CoEs should directly support the development and manufacturing capacity of ATMP-related biotechnologies, such as cell and gene therapy platforms, manufacturing infrastructure, and scale-up processes.
Each potential CoE should be an existing centre embedded within a vibrant biocluster (i.e. within proximity to pharmaceutical companies and research institutes) and should already benefit from critical infrastructure and services necessary to advance from lab to patient such as knowledge transfer support, state-of-the-art GMP[5] and clinical trials facilities. In addition, the centre should be performing the full spectrum of life sciences research, from discovery to clinical trials and should have demonstrated leadership in the field through a stand-alone research programme. Each CoE is expected to become world-class by further embedding itself in the full value chain and seeking additional political and financial support at regional, national and European level. The network should be limited to no more than 10 CoEs across the EU, with complementary expertise in the various ATMP technologies.
The proposed European network of CoEs for ATMPs should include multiple stakeholders beyond the research community and/or established academic centres, including Member State ministries, regional representatives, funders, regulators and healthcare payers, industry actors, patient organisations and policymakers. The European Commission's Joint Research Centre (JRC) may participate as a member of the consortium selected for funding, bringing its expertise in pre-normative research, standardisation, regulatory advice and access to its research infrastructure.
To align with STEP eligibility, activities supported under this topic should demonstrate how they contribute to either: i) bringing innovative, cutting-edge technologies with strong economic potential to the internal market, or ii) reducing or preventing the Union’s strategic dependencies in the field of advanced therapies.
Proposals should be of limited duration (2027-2030) and cover at a minimum the following activities:
- Identify common needs and challenges related to ATMP R&D, as well as develop relevant policy recommendations related to clinical trials, manufacturing, logistics, regulatory (including harmonisation of market access authorisation and reimbursement procedures), public acceptance, policies for transnational care, and coordination with national/regional healthcare systems etc.
- Develop a roadmap to ensure that Europe becomes the global leader for ATMP R&I by 2035, with clearly defined milestones, targets and Key Performance Indicators (KPIs). The roadmap should align with national R&D plans and include a long-term funding strategy. Appropriate measures should be considered to expand or widen the network during the roadmap’s implementation.
- Create an advisory board with diverse stakeholders, as a forum to provide guidance and advice for ensuring maximum utility of the generated outputs.
- Develop common education and training programmes for the next generation of scientists including outreach activities to better inform i) the public and patients on the benefits of ATMPs and ii) the stakeholders about access to the CoEs facilities and support.
Proposals should build on the experiences and outcomes of previous or ongoing actions such as RESTORE[6], Join4ATMP[7], PRECISEEU[8] and T2EVOLVE[9], and liaise with the relevant partnerships such as the co-funded European Partnership on Rare Diseases[10], the co-funded European Partnership for Personalised Medicine[11] and the Innovative Health Initiative Joint Undertaking (IHI-JU)[12] as appropriate.
[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] Committee for Advanced Therapies (CAT) quarterly highlights and approved ATMPs Feb-May 2025: https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-may-2025_en.pdf
[3] The future of European competitiveness, Mario Draghi: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en
[4] Advanced Therapy Medicinal Products - EATRIS: https://eatris.eu/atmp
[5] Good Manufacturing Practices: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
[6] https://cordis.europa.eu/project/id/820292
[7] https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/how-to-participate/org-details/999999999/project/101137206/program/43108390/details, https://cordis.europa.eu/project/id/101137206
[8] https://cordis.europa.eu/project/id/101161301
[9] https://cordis.europa.eu/project/id/945393
[10] https://cordis.europa.eu/project/id/101156595, https://erdera.org
[11] https://cordis.europa.eu/project/id/101137129, https://www.eppermed.eu
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
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
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).
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner. The JRC will not participate in the preparation and submission of the proposal - see General Annex B.
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
Eligible proposals submitted under this topic and exceeding all the evaluation thresholds will be awarded a STEP Seal [[https://strategic-technologies.europa.eu/about/step-seal_en]].
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
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 CSA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE CSA) - 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
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.
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