Translating Disruptive New Approach Methodologies (NAMs) into Practice

The HORIZON-EIC-2026-AIC-02 call, titled "Translating Disruptive New Approach Methodologies (NAMs) into Practice," is part of the EIC Advanced Innovation Challenge under the Horizon Europe program. This initiative aims to bolster the health sector in Europe by advancing the development and practical application of innovative NAMs in biomedicine, with a focus on alternatives to animal testing. The call is designed specifically for single legal entities, including start-ups, SMEs, and research-performing organizations, established in EU Member States or Associated Countries. Notably, larger companies that do not qualify as SMEs are ineligible to apply.

The funding mechanism is a lump sum grant, with a total budget of €6,000,000 available for this topic. Each grant has a minimum contribution of €300,000, providing around ten expected grants. The application process follows a two-stage model: Stage 1 focuses on validation and benchmarking, while Stage 2 involves more advanced development and user testing. Applicants are required to demonstrate the viability of their proposed solutions at Technology Readiness Level (TRL) 4 and must secure endorsements from industry stakeholders or regulatory bodies for their projects to enhance prospects for long-term impact.

Stage 1 emphasizes solution validation, where participants engage with regulatory authorities and industry stakeholders to establish a roadmap for adoption and assess performance. Successful Stage 1 applicants may progress to Stage 2, where they must develop a scalable NAM prototype aimed at regulatory and clinical uptake. Throughout the process, beneficiaries will receive comprehensive support, including access to Business Acceleration Services, which provide coaching, mentorship, and networking opportunities.

The call is now open for submissions starting December 3, 2025, and will conclude on February 26, 2026, with a 5 PM deadline in Brussels time. The call explicitly invites proposals that leverage technologies capable of transforming biomedical research and testing methodologies, with an aim to produce safer, more effective health products.

This is a description of the HORIZON-EIC-2026-AIC-02 call, titled "Translating Disruptive New Approach Methodologies (NAMs) into Practice," which is part of the EIC Advanced Innovation Challenge (HORIZON-EIC-2026-AIC) under the Horizon Europe (HORIZON) program. The call aims to maintain and strengthen the health sector in Europe by accelerating the development and validation of disruptive New Approach Methodologies (NAMs) for biomedical applications, supporting regulatory innovation, enabling citizens to benefit from novel technologies, and providing industry with a harmonized and standardized NAM-based assessment toolkit.

The call is a two-stage challenge competition. The ultimate goal is to deliver robust, validated NAMs that constitute a representative model or prototype system, achieving Technology Readiness Level (TRL) 6 by the end of Stage 2. Applicants should only apply to Stage 1 if there is a clear outlook for potential long-term impact.

Stage 1 focuses on solution validation and benchmarking. Applicants are expected to engage with regulatory authorities, notified bodies, and industry stakeholders; map regulatory, clinical, standardization, and industrial needs to develop a roadmap for adoption; develop a methodology for performance assessment; conduct small-scale feasibility experiments or modeling; perform initial performance benchmarking; and assess ethical, data governance, and scalability considerations. Key milestones for Stage 1 include demonstrating the viability of the NAM for human-relevant biomedical innovation, addressing identified use cases, securing commitment from industrial end-users, and establishing a well-defined regulatory plan for Stage 2. Progress to Stage 2 is contingent on delivering a full proposal assessed alongside the milestones achieved in Stage 1.

Stage 2 involves development and user testing. Selected applicants will further develop and validate a functional, scalable NAM prototype for regulatory, industrial, or clinical uptake. Activities include benchmarking NAMs against state-of-the-art animal models and/or human trials; demonstrating relevant applications such as disease modeling or testing medicinal products and medical technologies; organizing consultation meetings/workshops with stakeholders; engaging with infrastructures for testing and data collection; developing regulatory-grade data packages for submission to agencies like EMA, FDA, and OECD; and documenting scalability, standardization, and potential barriers to uptake. During project implementation, beneficiaries are encouraged to use the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) for standardization, automation, and validation of in vitro methods.

The scope of the call focuses on innovative and disruptive NAMs that can replace, reduce, or refine animal use in the testing of medicinal products. Proposals should address preclinical biomedical research or the testing of medicinal products and medical technologies for safety, efficacy, or quality. Relevant NAMs include human organoids or microphysiological systems (e.g., organ-on-chip, disease-on-chip), in chemico methods, digital twins, virtual patient simulations, AI-enhanced predictive models, mechanistic or integrated in silico platforms, and 3D-advanced human tissue models.

Applicants should have proven the viability of their proposed solution in a lab environment at TRL 4 (lab or in silico), have letters of intent from at least one industrial end-user or regulatory body, and have access to an appropriate infrastructure for activities in Stages 1 and 2.

The call is open for submission by a single legal entity established in a Member State or an Associated Country if the entity is a start-up, SME, or research performing organization. Larger companies that do not qualify as SMEs are not eligible to apply as a single legal entity. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. The list of eligible countries is detailed in Annex 2 of the EIC Work Programme 2026, and financial and operational capacity and exclusion criteria are described in Annex 2(C) of the same work program. The Model Grant Agreement (MGA) used for EIC actions under Horizon Europe applies. Specific conditions are described in Section IV of the EIC Advanced Innovation Challenges- Pilot of the EIC Work Programme 2026.

The budget for the call is EUR 6,000,000 for the year 2026. The call is a single-stage submission model, opening on December 3, 2025, and closing on February 26, 2026, at 17:00:00 Brussels time. The indicative number of grants is 10, with contributions of around EUR 300,000 per grant.

Additional documents include the EIC Work Programme 2026, EU Financial Regulation 2024/2509, the Decision authorizing the use of lump sum contributions under the Horizon Europe Programme, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, the EU Grants AGA — Annotated Model Grant Agreement, the Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and the Funding & Tenders Portal Privacy Statement.

The call aims to accelerate the development and adoption of new methodologies that reduce or replace animal testing in biomedicine. It seeks to support companies in bringing these innovative NAMs to the market, ultimately strengthening the European health sector and benefiting citizens through safer and more effective health products. The two-stage approach allows for initial validation and benchmarking, followed by further development and user testing to ensure the NAMs are robust, scalable, and ready for regulatory and industrial uptake.

Eligible Applicant Types: Startups, SMEs, research performing organizations (universities, research or technology organizations, including teams, individual Principal Investigators and inventors) are eligible as single legal entities (mono-beneficiary). Larger companies (i.e., those not qualifying as SMEs) are not eligible to apply as a single legal entity. The applicant must be established in a Member State or an Associated Country.

Funding Type: Grant. Specifically, HORIZON EIC Grants and HORIZON Lump Sum Grants are mentioned.

Consortium Requirement: Single. Only a single legal entity can apply, except for larger companies which are not eligible as single applicants.

Beneficiary Scope (Geographic Eligibility): EU Member States and Associated Countries are eligible. The specific list of eligible countries is detailed in Annex 2 of the EIC Work Programme 2026.

Target Sector: Health, biomedicine, medicinal products, medical technologies, and related areas using New Approach Methodologies (NAMs). Specific technologies mentioned include: Human organoids, microphysiological systems (e.g., organ-on-chip, disease-on-chip), in chemico methods, digital twins, virtual patient simulations, AI-enhanced predictive models, mechanistic or integrated in silico platforms, and 3D-advanced human tissue models.

Mentioned Countries: EU Member States, Associated Countries, and third-countries are mentioned in the context of National Contact Points (NCPs). The United States is mentioned as the location of the FDA.

Project Stage: The call targets projects that have already proven viability in a lab environment at TRL 4 (lab or in silico). The ultimate ambition is to deliver robust, validated NAMs that constitute a representative model or prototype system i.e. achieve TRL 6 after Stage 2.

Funding Amount: The budget for the topic is EUR 6,000,000. The indicative contribution is around EUR 300,000 per grant.

Application Type: Open call. The call is a two-stage Challenge competition.

Nature of Support: Money. Beneficiaries will receive funding to develop and validate their NAM prototypes.

Application Stages: 2. Stage 1 involves solution validation and benchmarking. Stage 2 involves development and user testing. Progress to Stage 2 is contingent on delivering a full proposal which will be assessed alongside the milestones achieved under Stage 1.

Success Rates: The indicative number of grants is 10, with around 300,000 contributions.

Co-funding Requirement: This information is not explicitly stated in the provided text.

Summary:

This is a two-stage EIC Advanced Innovation Challenge under the Horizon Europe program, specifically targeting the development and validation of New Approach Methodologies (NAMs) in biomedicine to reduce or replace animal testing. The challenge aims to accelerate the adoption of innovative and disruptive NAMs by supporting companies in bringing these methodologies to market. Eligible applicants are startups, SMEs, and research performing organizations from EU Member States and Associated Countries. Larger companies cannot apply as single entities. The funding is provided as a grant, with an indicative contribution of around EUR 300,000 per grant, from a total budget of EUR 6,000,000. The application process involves two stages: Stage 1 focuses on solution validation and benchmarking, while Stage 2 involves further development and user testing of a functional, scalable NAM prototype. The ultimate goal is to achieve TRL 6, resulting in a robust, validated NAM prototype ready for regulatory, industrial, or clinical uptake. The call encourages applicants to engage with regulatory authorities, industry stakeholders, and relevant infrastructures for testing and data collection. The scope includes preclinical biomedical research and testing of medicinal products and medical technologies for safety, efficacy, or quality, with a focus on technologies like human organoids, microphysiological systems, digital twins, and AI-enhanced predictive models. Applicants should already have proven the viability of their solution at TRL 4 and have letters of intent from industrial end-users or regulatory bodies. The opening date for submission is December 3, 2025, and the deadline is February 26, 2026.