Integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2026-01-TOOL-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-TOOL-03HORIZON-HLTH-2026-01Acute toxicityBasic medicineBiological basis of immunity related disorders (e.g. autoimmunity)Biomaterial engineeringBiomedical engineeringCancer and its biological basisCardiac and Cardiovascular systemsCardiovascular diseasesChronic toxicityDevelopmental toxicityDisease determinantsDrug development, clinical phasesDrug diseasesEmerging EpidemicsEndocrinologyEndocrinology and metabolism (including diabetes, hormones)Environmental healthEnvironmental risk measurementGlobal healthHealth-related biotechnologyHuman geneticsMedical biotechnologyMetabolomicsNeurological disorders (e.g. Alzheimer's disease, Huntington's disease, Parkinson's disease)ObesityPharmacodynamicsPharmacokineticsPhotonicsPhysiology (including cytology)Psychiatric disorders (e.g. schizophrenia, autism, Tourette's syndrome, obsessive compulsive disorder, depression, bipolar disorder, attention deficit hyperactivity disorder)Respiratory systemsSafety PharmacologyTechnologies involving the manipulation of cells, tissues, organs or the whole organism (assisted reproduction)Tissue banksTissue engineeringToxicology
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 several of the following expected outcomes:
- Researchers are in possession of improved human-relevant New Approach Methodologies (NAMs) platforms that capture the genetic, phenotypic, age-related, immune, microbiome, and environmental exposure variability of the human population. These innovations support more equitable healthcare solutions and personalised treatment strategies across diverse life stages.
- Industry gets access to platforms that allow a faster pace of innovation for the development of more cost-effective targeted therapeutic interventions and improvement of the safety assessment of chemicals, other medicinal products, and medical devices.
- Patients benefit from innovative platforms and strategies that improve prediction, prevention and treatment of diseases, in particular through enhanced understanding of disease pathways and mechanisms.
- The general population is better protected through a safer environment, as these platforms enhance the detection and mitigation of risks posed by chemicals and other potentially harmful substances.
- Regulatory bodies gain confidence and trust in NAMs, supporting their integration into product development, risk assessment, and approval processes.
- Fewer live animals are used in biomedical research and regulatory testing.
This topic aims to support the ongoing paradigm shift in biomedical research and safety assessment of chemical compounds by fully integrating NAMs across the entire research and regulatory spectrum, from basic discovery phase to clinical application, and regulatory testing of medicinal products and medical devices, and/or industrial and environmental chemicals.
NAMs include a wide range of innovative and human-relevant technologies such as in-vitro or human ex-vivo assays, organoids, Organ-on-Chip (OoC) systems, human tissue models, induced Pluripotent Stem Cell (iPSC) applications, virtual twin tools, in-silico methods, and Artificial Intelligence (AI)-driven modelling.
Although the Commission and several Member States have supported the development of NAMs for over two decades, primarily in the context of chemical risk assessment, regulatory uptake remains limited. There is a need to address this situation by delivering validated NAMs solutions that can be adopted by industry and accepted by the regulators for the safety assessment of chemicals. In parallel, there is a growing readiness to expand the development and application of NAMs across the entire biomedical research spectrum, from early discovery through to clinical translation and regulatory testing of medicinal products and medical devices.
Proposals should bring together stakeholders from academia, health-related infrastructures, SMEs[1], industry, and regulators to develop new NAMs platforms or improve existing ones that could be used for biomedical applications and/or regulatory testing. For biomedical applications, these platforms should enhance disease modelling precision, especially in areas where current animal models are of limited human relevance, and where NAMs could effectively complement or replace animal studies. For proposals addressing regulatory use, in particular the safety assessment of chemicals, other medicinal products and medical devices, the intended context(s) of use should be clearly defined, with validation strategies and methodologies aligned with current OECD and/or European Medicines Agency (EMA) guidance. Early, proactive, and sustained engagement with regulators should also be demonstrated.
Proposals should develop or optimise scalable and reproducible platforms based on one or more of the following:
- Advanced in-vitro assays.
- iPSC-based models, organoid or complex OoC systems derived from patients and/or healthy donors.
- Human tissues that closely replicate physiological and pathological conditions.
In order to enable real-time monitoring of physiological responses, proposals should consider integration of embedded sensors. They should also address biological diversity, reflecting variations in genetics, phenotype, age, immune status, and microbiome across the population.
Moreover, proposals may incorporate one or both of the following complementary approaches to enhance predictive power and clinical relevance:
- AI-driven predictive modelling trained on high-quality, curated, bias-minimised datasets to predict outcomes of biomedical interventions, or risk assessment.
- Virtual twin technology to simulate disease progression, responses to interventions, and support the optimisation of clinical trials.
To maximise scientific impact, interoperability, and reuse, all data generated should comply with FAIR[2] principles. Proposals should describe how data will be curated, standardised, and shared within or linked to the European Health Data Space (EHDS)[3] or other repositories, and/or relevant ESFRI[4] research infrastructures.
In order to optimise synergies and increase the impact of the projects, all proposals selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities.
Proposals should consider involving the European Commission's Joint Research Centre (JRC), including its EU Reference Laboratory for alternatives to animal testing (EURL ECVAM)[5], to take advantage of its expertise and relevant activities in bridging research and application communities and facilitating uptake of NAMs in biomedical research and regulatory testing. In that respect, the JRC should collaborate with any successful proposal and this collaboration should be established after the proposal’s approval.
Applicants envisaging to include clinical studies[6] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.
[1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[2] See definition of FAIR data in the introduction to this Work Programme part.
[4] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu
[6] 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
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).
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.
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
In order to maximise synergies and increase the impact of the projects, all proposals selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). These activities will be included in a dedicated work package, having sufficient budget allocated to it (around 2% of the total requested budget). Depending on the scope of proposals selected for funding, these activities may include:
- Attendance of regular joint meetings (e.g. common kick-off meeting and annual meetings).
- Periodic report of joint activities (delivered at each reporting period).
- Common dissemination and communication activities (which may include, for example: a common dissemination and communication strategy, web portal and visual identity, brochure, newsletters).
- Common Data Management Strategy and Common Policy Strategy (including joint policy briefs).
- Thematic workshops/trainings on issues of common interest.
- Working groups on topics of common interest (e.g. data management and exchange, communication and dissemination, science-policy link, scientific synergies).
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
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’).
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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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