Integrating New Approach Methodologies (NAMs) – what Horizon Europe expects from the HLTH-2026-01-TOOL-03 call topic
27th October 2025 at 10:33 am
The European Commission (EC) aims to accelerate a paradigm shift in biomedical research and chemical safety testing. Traditional animal models have contributed immensely to scientific progress, but often fail to predict human outcomes. The Research and Innovation Action (RIA) HORIZON-HLTH-2026-01-TOOL-03 call topic addresses this challenge by supporting 7 projects that fully integrate New Approach Methodologies (NAMs) across the research-to-regulation spectrum. With about six months left until the deadline on 16 April 2026, now is the perfect time to put together a competitive consortium and prepare your application to apply for € 5.00 to € 8.00 million. Dive into this blog post to explore the main expectations of the call topic’s scope and learn how to design proposals that translate scientific innovation into real-world impact.
1. The paradigm shift: from animal models to NAMs integration
NAMs include in-vitro and human ex-vivo assays, organoids, Organ-on-Chip (OoC) systems, iPSC-derived models, AI-driven simulations and virtual twin tools. They promise better translation to human biology and fewer animal experiments. The EC now expects proposals that move beyond proof-of-concept to integration across discovery, clinical application and regulatory testing.
Tips for applicants:
- Identify research areas where existing animal models show poor predictive value.
- Demonstrate how your NAM platform addresses this gap and increases clinical relevance.
- Explain how integration across different research stages will improve reproducibility and accelerate innovation.
- Highlight benefits for patients, regulators and industry equally.
- Link your approach to the EU’s long-term goals under the 3Rs principle, the Chemicals Strategy for Sustainability and the REACH Regulation to show alignment with broader policy objectives.
2. Building human-relevant, scalable platforms
Projects should develop or optimise scalable and reproducible platforms such as advanced in-vitro assays, patient-derived iPSC systems or complex OoC models. The call explicitly encourages inclusion of embedded sensors to enable real-time monitoring of physiological responses and stresses the importance of biological diversity.
Tips for applicants:
- Justify your choice of model and explain how it replicates physiological or pathological conditions.
- Show how the system incorporates genetic, phenotypic, age-related and microbiome variability.
- Include plans for miniaturisation, automation or standardisation to ensure scalability.
- Describe how embedded sensors or advanced readouts strengthen your capacity for real-time data capture.
3. Validation and regulatory alignment
Limited regulatory uptake has been one of the main bottlenecks for NAMs. The EC expects proposals to define their intended context of use and include validation plans aligned with current OECD and European Medicines Agency (EMA) guidance. Early, proactive engagement with regulators is essential.
Tips for applicants:
- Define the context of use clearly: whether for biomedical research, drug development or chemical safety.
- Outline a stepwise validation roadmap including intra- and inter-laboratory reproducibility testing.
- Plan early interactions with relevant regulatory bodies or standardisation organisations and consider adding a regulatory or standardisation expert to your consortium to ensure validation and communication strategies meet EC expectations.
- Describe how results will support future guideline development or inclusion in regulatory frameworks.
4. Making data FAIR and interoperable
The call requires all data generated to comply with FAIR principles and encourages links to the European Health Data Space (EHDS) or relevant ESFRI research infrastructures. Strong data governance demonstrates responsibility and enhances reuse potential.
Tips for applicants:
- Include a data management plan describing how information will be standardised, annotated and shared.
- Align metadata and file formats with accepted ontologies or repositories.
- Build interoperability into your platform from the start rather than as an afterthought.
- Describe quality assurance procedures for data curation and bias control.
5. Creating diverse, balanced consortia
The Commission expects broad cooperation between academia, SMEs, industry and regulators. A successful consortium will combine scientific excellence with translational, ethical and regulatory insight.
Tips for applicants:
- Bring together partners with complementary expertise: biology, modelling, AI, data science and regulatory affairs.
- Involve end users such as hospitals, chemical companies or agencies early in project design.
- Ensure representation of diverse human populations in data sources and biological materials.
- Integrate social sciences and ethics experts to anticipate societal and legal implications.
- Include clear plans for stakeholder engagement and dissemination to strengthen your impact pathway and evaluator confidence.
6. Demonstrating clinical and societal value
Ultimately, the Commission wants to see NAMs that improve disease prediction, prevention and treatment, while reducing reliance on animal models. Successful proposals will show how these new platforms deliver tangible benefits for patients and regulators.
Tips for applicants:
- Describe how your NAMs could complement clinical studies or support personalised medicine.
- Illustrate how your results will feed into public health protection, safer products or faster drug development.
- Quantify expected gains in cost efficiency, time reduction or ethical compliance.
Looking for proposal writing support from experts with biomedical experience?
Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. At accelopment, we have been supporting consortia in the HORIZON Health projects GENEGUT, EXPOSIM, EU PAL-COPD, GLIOMATCH, COVend and MyPath. Additionally, our support extends to many more health-focused ITNs, including MITGEST and MobiliTraIN, as well as Pathfinder-Open projects related to health, such as POLINA and BoneOscopy.
The call HORIZON-HLTH-2026-01-TOOL-03 offers a unique opportunity to make human-relevant, validated and interoperable NAMs the new standard in biomedical research and regulatory testing. Are you preparing a proposal for this call topic? Contact our Horizon Health experts for strategic guidance on proposal design, partner coordination and regulatory alignment. Together, we can help you turn your innovative NAMs concept into a competitive Horizon Europe proposal.
