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HORIZON-HLTH-2026-01-TOOL-06

Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices

CSA Cluster 1 €2,900,000 16 Apr 2026
Topic Code HORIZON-HLTH-2026-01-TOOL-06 F&T Portal
Call Identifier HORIZON-HLTH-2026-01 Call 01 — single stage (2026)
Instrument HORIZON-CSA Coordination and Support Action
Budget Model Lump Sum HORIZON-AG-LS
Funding Rate 100% Annex G — CSA = 100%
Page Limit (Part B) 28 pages CSA + lump sum (Annex A)
Evaluation Thresholds 4 / 4 / 4 · cum. 12 Non-standard — topic override
Expected Projects 1 ~€2.9M per project (WP stated)
Destination Developing and using new tools, technologies and digital solutions for a healthy society WP Part 4
Cluster / Pillar Cluster 1 / Pillar II Health
China Eligibility Eligible ✓ CSA not restricted (RIA/IA only)
Special Conditions ERA action participant Coordinator: active ERA participant
Verify: Open this topic on the F&T Portal →  ·  Sources: General Annexes 2026-2027, WP Part 4
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China is eligible for this topic. The destination’s China restriction applies to RIA and IA only — CSA is not restricted.
This topic uses non-standard evaluation thresholds: 4 (Excellence) / 4 (Impact) / 4 (Implementation), cumulative 12. Standard thresholds are 3/3/3 cumulative 10.
US entities eligible: In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America are eligible to receive Union funding under this topic.
Copernicus/Galileo: If the project uses satellite-based earth observation, positioning, navigation and/or related timing data, beneficiaries must make use of Copernicus and/or Galileo/EGNOS.

Expected Outcomes

  1. Member States and relevant stakeholders identify priority areas where New Approach Methodologies (NAMs) and infrastructures are most needed and expected to have the highest short- to medium-term impact.
  2. Member States and other stakeholders jointly support the validation and qualification of a limited set of NAMs that are intended to be accepted and implemented in regulatory testing of medicinal products and medical devices.
  3. Member States and other stakeholders develop common education and training programmes based on best practices identified in European and non-European countries to better inform researchers and regulators on NAMs and on the application of the 3Rs principles.
  4. Member States and other stakeholders implement a harmonised NAM openness and awareness programme that improves open access to NAMs protocols and results of animal experiments. It also provides guidance to harmonise the awareness of NAMs for ethical committee members, reviewers, and regulators, based on best practices in the participating Member States. The programme should propose concrete actions to increase the confidence of regulators in NAMs including a better understanding of the potential and limitations of NAMs.

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