Integration of New Approach Methodologies (NAMs)

Official call identifier: HORIZON-HLTH-2026-01-TOOL-03 

Objective of the call

This call aims to accelerate the transition from animal-based models to human-relevant New Approach Methodologies (NAMs) in biomedical research and regulatory testing. 

It supports the development and validation of scalable platforms such as organoids, Organ-on-Chip systems and AI-based predictive models to improve disease modelling, drug discovery and chemical safety assessment. 

The call also seeks to strengthen regulatory acceptance and promote FAIR data sharing through European infrastructures. 

Scope of activities 

Projects are expected to: 

• Develop and optimise advanced in-vitro assays, iPSC-based organoids, Organ-on-Chip systems and human tissue models with embedded sensors 

• Address population diversity factors such as genetics, age and microbiome 

• Integrate AI models or virtual twins to enhance predictive and clinical relevance 

• Align with OECD and EMA regulatory frameworks and engage regulators early 

• Collaborate within a project cluster and cooperate with JRC/EURL ECVAM 

Eligible applicants 

• Innovative SMEs, startups and enterprises aiming to scale and strengthen competitiveness 
• Public-sector organisations driving transformation and societal impact 
• Research and academic institutions commercialising knowledge 
• Non-profit organisations delivering purpose-driven innovation 
• Organisations based in EU Member States, EFTA/EEA, or Associated Countries (described in General Annex A, General Annex B, General Annex C)
• Minimum 3 independent partners from 3 eligible countries 

Specific consortium we are looking for:

• Universities and biomedical research organisations 
• Regulatory bodies and validation authorities 
• Pharmaceutical, biotechnology and chemical industry partners 
• Health research infrastructures and specialised SMEs 

Eligible costs 

Eligible costs follow standard Horizon Europe Research and Innovation Action (RIA) rules and include: 

• Personnel costs 

• Equipment and infrastructure use 

• Subcontracting and services 

• Travel and dissemination 

• Costs related to data management and regulatory validation 

Funding conditions 

Type of action: 
Research and Innovation Action (RIA) 

Funding rate: 
100% of eligible costs 

EU contribution per project: 
Around EUR 7 million 

Number of funded projects: 
7 project 

Project duration: 
Typically 36 months 

Technology Readiness Level (TRL): 
Activities may start at any TRL

*Technology Readiness Levels (TRL) describe the maturity of a technology, from basic research (TRL 1) to fully deployed, market-ready solutions (TRL 9).

Deadline for submission

16 April 2026