Integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing

The Horizon Europe call under the health cluster, identified as HORIZON-HLTH-2026-01-TOOL-03, focuses on integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing. This specific call is structured as a single-stage submission process, opening on February 10, 2026, and closing on April 16, 2026, at 17:00 CEST. It has an overall budget of €49 million, with funding available for seven projects, each receiving between €5 million and €8 million.

Eligible applicants include a diverse range of stakeholders, necessitating the formation of consortia that incorporate academia, health-related infrastructures, small and medium-sized enterprises (SMEs), industry partners, and regulatory bodies. The initiative is open to entities from EU member states, associated countries, and select non-EU countries, including the United States.

The core aim of the call is to support the development and validation of innovative, human-relevant platforms that replace traditional animal testing methods in biomedical and safety assessments. Targeted areas include advanced in-vitro technologies, organ-on-chip systems, and artificial intelligence-driven models, among others. Proposals are expected to address enhancing disease modeling and safety assessments while demonstrating early engagement with regulatory bodies and employing clear validation strategies.

Projects funded through this mechanism will be required to participate in collaborative cluster activities, which include joint networking, data management, and dissemination efforts, with an approximate allocation of 2% of the total budget for these activities. The evaluation of proposals will focus on three main criteria—excellence, impact, and implementation—each requiring a minimum score of 4, with a cumulative threshold of 12 points.

This opportunity represents a significant investment in ethical and efficient research methodologies aimed at improving healthcare solutions and reducing reliance on animal testing. The emphasis on collaboration across various sectors is intended to build a comprehensive approach to transforming biomedical research and regulatory processes.

This is a Horizon Europe (HORIZON) call under Cluster 1 Health (Single stage 2026) (HORIZON HLTH 2026 01). The topic is Integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing, with topic ID HORIZON HLTH 2026 01 TOOL 03. It is a HORIZON RIA (Research and Innovation Actions) with a HORIZON Lump Sum Grant [HORIZON AG LS] type of Model Grant Agreement (MGA). The deadline model is single stage. The planned opening date is 10 February 2026, and the deadline date is 16 April 2026 at 17:00:00 Brussels time.

The expected outcomes of this topic are:

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.

The scope of this topic is 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.

Proposals should bring together stakeholders from academia, health-related infrastructures, SMEs, 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 principles. Proposals should describe how data will be curated, standardised, and shared within or linked to the European Health Data Space (EHDS) or other repositories, and/or relevant ESFRI 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), 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 should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.

Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.

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.

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.

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.

Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 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.

Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.

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). Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

The standard application form (HE RIA, IA) and standard evaluation form (HE RIA, IA) are available in the Submission System.

Guidance documents include the HE Programme Guide, Model Grant Agreement (MGA), Lump Sum MGA, call-specific instructions, Information on clinical studies (HE), Detailed budget table (HE LS), and Guidance: "Lump sums - what do I need to know?".

Additional documents include the 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 Programme Guide, 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, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

The budget overview for 2026 includes various topics, each with a specified budget, stage (single-stage), opening date (2026-02-10), deadline (2026-04-16), contribution amounts, and indicative number of grants. The topics include HORIZON-HLTH-2026-01-CARE-01, HORIZON-HLTH-2026-01-CARE-03, HORIZON-HLTH-2026-01-DISEASE-02, HORIZON-HLTH-2026-01-DISEASE-03, HORIZON-HLTH-2026-01-DISEASE-04, HORIZON-HLTH-2026-01-DISEASE-09, HORIZON-HLTH-2026-01-DISEASE-11, HORIZON-HLTH-2026-01-DISEASE-15, HORIZON-HLTH-2026-01-ENVHLTH-01, HORIZON-HLTH-2026-01-ENVHLTH-04, HORIZON-HLTH-2026-01-ENVHLTH-05, HORIZON-HLTH-2026-01-IND-03, HORIZON-HLTH-2026-01-STAYHLTH-02, HORIZON-HLTH-2026-01-STAYHLTH-03, HORIZON-HLTH-2026-01-TOOL-03, HORIZON-HLTH-2026-01-TOOL-05, HORIZON-HLTH-2026-01-TOOL-06, and HORIZON-HLTH-2026-01-TOOL-07.

There are 5 partner search announcements available.

This Horizon Europe call aims to revolutionize biomedical research and chemical safety assessment by promoting the use of New Approach Methodologies (NAMs) as alternatives to animal testing. It encourages collaborative projects that bring together researchers, industry, SMEs, and regulatory bodies to develop and validate innovative NAMs platforms. These platforms should enhance disease modeling, improve safety assessments, and ultimately reduce the reliance on animal models. The call supports a wide range of technologies, including in-vitro assays, organoids, Organ-on-Chip systems, iPSC-based models, and AI-driven modelling. Successful projects will contribute to more effective healthcare solutions, safer products, and a more ethical research environment. The call also emphasizes data sharing and collaboration to maximize the impact of funded projects.

Eligible Applicant Types: The eligible applicant types for this opportunity are academia, health-related infrastructures, SMEs, industry, and regulators. The call specifies that proposals should bring together stakeholders from these groups. Any legal entity established in the United States of America is also eligible to receive Union funding. The Joint Research Centre (JRC) may participate as a member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner.

Funding Type: The funding type for this opportunity is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) and HORIZON Coordination and Support Actions (HORIZON-CSA) and HORIZON Public Procurement of Innovative Solutions (HORIZON-PPI) and HORIZON Innovation Actions (HORIZON-IA). The eligible costs will take the form of a lump sum.

Consortium Requirement: The opportunity requires a consortium of multiple applicants. Proposals should bring together stakeholders from academia, health-related infrastructures, SMEs, industry, and regulators.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU member states, associated countries, and potentially non-EU/non-associated countries with specific provisions. A legal entity established in the United States of America is also eligible to receive Union funding.

Target Sector: The target sector is health, specifically biomedical research, safety assessment of chemicals, medicinal products, and medical devices. It focuses on integrating New Approach Methodologies (NAMs) and digital solutions for a healthy society. Technologies include in-vitro and ex-vivo assays, organoids, Organ-on-Chip systems, human tissue models, induced Pluripotent Stem Cell applications, virtual twin tools, in-silico methods, and Artificial Intelligence-driven modelling.

Mentioned Countries: United States of America.

Project Stage: The project stage ranges from research and development to validation, clinical translation, and regulatory testing. The focus is on developing and optimizing scalable and reproducible NAMs platforms for biomedical applications and regulatory testing.

Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from approximately €1.9 million to €11 million. For example, HORIZON-HLTH-2026-01-TOOL-03 has a budget of €49 million with contributions ranging from €5 million to €8 million, while HORIZON-HLTH-2026-01-DISEASE-15 has a budget of €1.9 million with contributions around €1.9 million.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process consists of a single stage.

Success Rates: The success rates are not explicitly mentioned in the provided text. However, the indicative number of grants for each topic is provided, which can be used to estimate the potential success rate based on the number of expected applications.

Co-funding Requirement: The text does not explicitly state a co-funding requirement. However, the lump sum funding model suggests that applicants need to manage their resources effectively within the allocated budget.

Summary: This Horizon Europe call aims to foster the development and integration of New Approach Methodologies (NAMs) in biomedical research and regulatory testing. It seeks to support a paradigm shift away from animal testing by promoting innovative, human-relevant technologies such as organoids, Organ-on-Chip systems, and AI-driven modelling. The call encourages collaboration between academia, industry, SMEs, health-related infrastructures, and regulatory bodies to create scalable and reproducible NAMs platforms. These platforms should enhance disease modelling, improve safety assessments, and facilitate the development of targeted therapeutic interventions. The call also emphasizes data standardization, interoperability, and sharing within the European Health Data Space. Successful projects will form a cluster to maximize synergies and participate in joint networking activities. Funding is provided as a lump sum grant, and the application process involves a single-stage submission. This initiative is designed to improve healthcare solutions, protect the general population from harmful substances, and reduce the reliance on animal testing in biomedical research and regulatory processes.