Translating Disruptive New Approach Methodologies (NAMs) into Practice

This Challenge supports ambitions to maintain and strengthen the health sector in Europe by accelerating the development and validation of disruptive New Approach Methodologies (NAMs) for biomedical applications, including medicinal products and medical technologies. It aims to support regulatory innovation through evidence-based recommendations for assessing safety, efficacy, and quality, and to provide industry with harmonised assessment toolkits. The ultimate ambition is to deliver robust, validated NAMs that constitute a representative model or prototype system and reach TRL 6. The competition has two stages, focusing on validation, benchmarking, and progression of human-relevant biomedical innovations.

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Agency	HORIZON (EU)
Region	EU
Country	N/A
Legal form	Company, NGO, Government organization, Private person, Other
Start date	3 Dec 2025
End date	26 Feb 2026
Max funding	Up to 300,000 EUR per grant
Budget	6,000,000 EUR (2026 call budget)
Coverage	Funding covers project activities addressing the scope and milestones defined per stage. Please refer to the Model Grant Agreement for detailed coverage.

Grant application conditions

Applicant Type	Start-up, SME, or research-performing organisation (including university, research or technology organisation, teams, individual Principal Investigators, or inventors) as a single legal entity.
Company size restriction	Larger companies (which do not qualify as SMEs) are not eligible to apply as a single legal entity.
Eligible Countries	Legal entities must be established in an EU Member State or Associated Country.
Technology Readiness Level (TRL)	Applicants should already have proven the viability of their solution at TRL 4 (lab or in silico).
Stakeholder engagement	Applicants need letters of intent from at least one industrial end-user or regulatory body interested in the proposed project.
Infrastructure requirements	Applicants must have access to appropriate infrastructure to carry out planned activities in both stages.
Stage progression	Progression from Stage 1 to Stage 2 is contingent on milestone achievement and full proposal assessment.
Admissibility	Proposals must comply with the page limit and layout described in the application form.
Financial and operational capacity	Described in Annex 2(C. Financial and Operational Capacity) of the EIC Work Programme 2026.
Legal and financial set-up	According to Model Grant Agreement used for EIC actions under Horizon Europe.
Documentation	https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-EIC-2026-AIC-02

Eligible expenses

Evaluation criteria

Business exclusions

Reporting

Application process

Application requirements