Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicin...

The HORIZON-HLTH-2026-01-TOOL-06 funding opportunity is a grant initiative under the Horizon Europe framework aimed at supporting the European Research Area (ERA) actions. It focuses on accelerating the adoption of New Approach Methodologies (NAMs) pertinent to biomedical research and testing of medicinal products and medical devices. This initiative, classified as a Coordination and Support Action (CSA), is designed to establish an EU-wide forum involving various stakeholders such as ministries, regulatory agencies, research funding organizations, academic institutions, and industry players including pharmaceutical companies, small and medium-sized enterprises (SMEs), and startups.

Eligible applicants include legal entities established in EU Member States and Associated Countries, with the potential for exceptional participation from entities in the United States. The funding type is a lump sum grant, amounting to €2.9 million for this specific topic, with one project expected to be funded. The application process is a single-stage submission occurring between February 10, 2026, and April 16, 2026.

The grant aims to harmonize policies and implementation strategies for NAMs, which focus on methodologies that replace, reduce, and refine animal testing in medical research and regulatory testing. The project involves four thematic Working Groups: Development of NAMs and infrastructures, Validation and acceptance of NAMs, Education and training on NAMs and 3Rs principles, and Openness and awareness to enhance access to NAMs data.

Prospective projects must demonstrate effective engagement with relevant stakeholders, ability to navigate regulatory landscapes, and facilitate knowledge sharing across various entities. The application requires a minimum score across three evaluation criteria—Excellence, Impact, and Implementation—with a cumulative threshold for funding consideration. The overall objective is to improve biomedical research and regulatory practices through enhanced acceptance and implementation of NAMs, thereby reducing dependence on animal testing while ensuring compliance with scientific and regulatory standards.

The financial management and operational procedures will follow a streamlined approach due to the predetermined lump sum grant structure. The success rate for this funding opportunity is estimated to be below 10%, reflecting the competitive nature of this call. The overall goal is to foster innovation in biomedical practices and streamline regulatory pathways, ensuring efficacy in medical product testing while adhering to ethical standards in research.

This is a Horizon Europe (HORIZON) call under Cluster 1 Health, specifically the HORIZON HLTH 2026 01 TOOL 06 topic, which focuses on supporting the European Research Area (ERA) action to accelerate New Approach Methodologies (NAMs) for biomedical research and regulatory testing of medicinal products and medical devices. It is a HORIZON Coordination and Support Action (CSA) with a lump sum grant type. The call is a single stage process, planned to open on February 10, 2026, with a deadline of April 16, 2026, at 17:00 Brussels time. The indicative budget for the topic is 2,900,000 EUR, with one grant expected to be awarded.

The expected outcomes of this topic include:
1. Identification of priority areas by Member States and stakeholders where NAMs and infrastructures are most needed.
2. Joint support from Member States and stakeholders for the validation and qualification of a limited set of NAMs for regulatory testing.
3. Development of common education and training programmes on NAMs and the 3Rs principles, based on best practices.
4. Implementation of a harmonised NAM openness and awareness programme to improve access to NAMs protocols and results, and to increase confidence in NAMs among regulators and ethical committees.

The scope of the topic involves coordinating and developing the new ERA policy action to accelerate the uptake of NAMs in biomedical research and regulatory testing. This includes establishing an EU wide forum with relevant stakeholders to harmonise policies and strategies for NAMs development and implementation. The selected proposal should be coordinated by an active participant in the ERA action and contribute to the implementation of themes from four thematic Working Groups (WGs):

WG1: Development of NAMs and common European infrastructures, focusing on opportunities for development and integration of NAMs, supporting infrastructures, and providing insight to governments and industry.
WG2: Validation, acceptance, and uptake of NAMs, defining optimal criteria for NAMs, proposing priorities for validation, and supporting joint validation efforts by Member States and industry.
WG3: Education and training, mapping existing programmes on NAMs and the 3Rs principles, and suggesting joint development of high quality education modules.
WG4: Openness and awareness, developing common policies to improve research openness, facilitating open access to protocols and results, and enhancing confidence in validated NAMs among regulators.

The European Commission's Joint Research Centre (JRC) may contribute to the selected proposal, particularly with activities on innovative in vitro biotechnologies.

The admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. Legal entities from the United States of America may exceptionally participate as beneficiaries or affiliated entities and are eligible to receive Union funding. Coordinators must be legal entities established in an EU Member State or Associated Country. Projects using satellite data must use Copernicus and/or Galileo/EGNOS. The JRC may participate as a member of the consortium with zero funding or as an associated partner but will not participate in proposal preparation and submission. Other eligibility conditions are described in Annex B of the Work Programme General Annexes.

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Award criteria, scoring, and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion (Excellence, Impact, Implementation) will be 4, with a cumulative threshold of 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is described in Annex F of the Work Programme General Annexes.

Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021. Legal and financial set up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates include the standard application form (HE CSA) and the standard evaluation form (HE CSA). Guidance documents include the HE Programme Guide, Model Grant Agreement (MGA), Lump Sum MGA, detailed budget table (HE LS), and guidance on lump sums. Additional documents include the HE Main Work Programme 2026 2027, HE Framework Programme 2021/695, EU Financial Regulation 2024/2509, and various rules and agreements related to legal entities, financial capacity, and grant management.

The Funding & Tenders Portal provides resources such as an Online Manual, FAQ, Research Enquiry Service, National Contact Points (NCPs), Enterprise Europe Network, IT Helpdesk, European IPR Helpdesk, CEN CENELEC Research Helpdesk, ETSI Research Helpdesk, the European Charter for Researchers, and a Partner Search tool.

In summary, this funding opportunity aims to coordinate and support the development and implementation of New Approach Methodologies (NAMs) within the European Research Area (ERA) to reduce reliance on animal testing in biomedical research and regulatory assessments. It seeks to bring together key stakeholders, harmonize policies, develop education programs, and promote open access to NAMs data and protocols, ultimately increasing confidence in and uptake of these methodologies for a healthier society. The funding is provided as a lump sum, and the project requires coordination by an active participant in the ERA action, with contributions to specific working groups focused on NAMs development, validation, education, and awareness.

This funding opportunity is about coordinating efforts across Europe to promote and implement new, non animal testing methods in biomedical research and regulatory testing. Think of it as a project to bring together different countries, research institutions, and companies to agree on how to best develop, validate, and use these new testing methods. The goal is to reduce the use of animals in research while still ensuring the safety and effectiveness of medicines and medical devices. The project will also focus on training researchers and regulators on these new methods and making sure that information about them is easily available to everyone.

Eligible Applicant Types: The eligible applicant types include ministries, regulatory agencies, research funding organisations, academia, industry (pharmaceutical and medical technology), Contract Research Organisations (CROs), small and medium-sized enterprises (SMEs), and startups. Coordinators of projects must be legal entities established in an EU Member State or Associated Country. Legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding. The European Commission's Joint Research Centre (JRC) may contribute to the proposal selected for funding.

Funding Type: The funding type is a grant, specifically a HORIZON Coordination and Support Action (HORIZON-CSA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] Model Grant Agreement (MGA). Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme.

Consortium Requirement: A consortium of multiple applicants is required. The ERA action should establish an EU-wide forum that brings together relevant stakeholders.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States, Associated Countries, and, exceptionally, the United States of America. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects.

Target Sector: The target sector is health, specifically focusing on biomedical research, regulatory testing of medicinal products and medical devices, pharmaceuticals, and medical technology. The program targets the development, validation/qualification, acceptance, and uptake of New Approach Methodologies (NAMs).

Mentioned Countries: United States of America, EU Member States, Associated Countries.

Project Stage: The project stage targets activities that enable or contribute to the expected impacts, including development, validation/qualification, acceptance, and uptake of NAMs. The project focuses on priority areas where NAMs and infrastructures are most needed and expected to have the highest short- to medium-term impact. It also focuses on the validation and qualification of NAMs that are sufficiently mature for acceptance and uptake in regulatory testing.

Funding Amount: The budget for the topic HORIZON-HLTH-2026-01-TOOL-06 is EUR 2,900,000. The indicative number of grants is 1.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves a single stage.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants is 1 for the topic HORIZON-HLTH-2026-01-TOOL-06.

Co-funding Requirement: The co-funding requirement is not explicitly mentioned.

Summary: This Horizon Europe grant opportunity, HORIZON-HLTH-2026-01-TOOL-06, aims to coordinate and develop the new European Research Area (ERA) policy action to accelerate the development, validation, acceptance, and uptake of New Approach Methodologies (NAMs) in biomedical research and regulatory testing of medicinal products and medical devices. This initiative is part of the ERA Policy Agenda 2025-2027 and seeks to establish an EU-wide forum involving various stakeholders, including ministries, regulatory agencies, research funding organisations, academia, industry (pharmaceutical and medical technology), Contract Research Organisations (CROs), SMEs, and startups. The selected proposal, a HORIZON Coordination and Support Action (CSA), should be coordinated by an active participant in the ERA action and contribute to the implementation of themes from four thematic Working Groups (WGs): development of NAMs and infrastructures, validation and acceptance of NAMs, education and training, and openness and awareness. The European Commission's Joint Research Centre (JRC) may also contribute. Eligible applicants include entities from EU Member States, Associated Countries, and, exceptionally, the United States. The funding will be provided as a lump sum, with approximately EUR 2,900,000 available for a single grant. The application process is a single-stage submission with a deadline of April 16, 2026. The overall goal is to foster the use of NAMs to improve biomedical research and regulatory testing, aligning policies and strategies across Europe.