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Call key data
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
Funding Program
Horizon Europe: Cluster 1 - Health
Call number
HORIZON-HLTH-2026-01-TOOL-06
deadlines
Opening
10.02.2026
Deadline
16.04.2026 17:00
Funding rate
100%
Call budget
€ 2,900,000.00
Estimated EU contribution per project
€ 2,900,000.00
Link to the call
Link to the submission
Call content
short description
This topic aims to coordinate and develop the new European Research Area (ERA) policy action to accelerate, through an aligned and coordinated approach across Member States and Associated Countries, the development, validation/qualification, acceptance, and uptake of NAMs (New Approach Methodologies) in biomedical research and regulatory testing of medicinal products and medical devices as part of the ERA Policy Agenda 2025-2027.
Call objectives
The ERA action should establish an EU-wide forum that brings together relevant ministries, regulatory agencies, research funding organisations, academia, industry (pharmaceutical and medical technology), Contract Research Organisations (CROs), small and medium-sized enterprises (SMEs), and startups to harmonise policies and strategies for NAMs development and implementation.
The selected proposal should be coordinated by any active participant to the ERA action to ensure consistency with ERA action policy objectives. It should contribute to the implementation of the following themes of the four thematic Working Groups (WGs) of the ERA action:
WG1: Development of NAMs and common European infrastructures. This WG identifies opportunities for the development and integration of NAMs and the establishment of supporting infrastructures. Its focus spans specific disease or biological areas and safety, quality, and efficacy assessment endpoints for medicinal products and medical devices. The WG provides insight and suggests priorities to governments and industry for the further coordinated efforts to leverage promising development of NAMs, taking into consideration the complementarity of scientific strengths, funding priorities and available expertise in the different Member States and regions.
WG2: Validation, acceptance, and uptake of NAMs. The WG defines optimal criteria for NAMs to facilitate their uptake in the contexts of basic and applied biomedical research, and their acceptance for the regulatory assessment and eventual approval of medicinal products and medical devices within defined contexts of use. It proposes priorities for the validation and qualification of NAMs. Member States and pharma/MedTech industry take the decision to jointly support the validation/qualification of certain NAMs that are sufficiently mature for acceptance and uptake in regulatory testing of medicinal products and medical devices.
WG3: Education and training. The WG maps existing education and training programmes on NAMs and the 3Rs principles and assesses their quality and outreach. The WG makes suggestions to Member States based on the best practices identified for the joint development of high-quality education and training modules on NAMs and the application of the 3Rs principles in close partnership with education directors at knowledge institutes.
WG4: Openness and awareness. The WG develops common policies to improve the openness and quality of research, including open access to available protocols on NAMs, and facilitating the publication of results from NAMs and animal experiments, even if these are negative or neutral (or historic, if feasible and appropriate), to avoid unnecessary duplication of animal testing or development of non-valid NAMs. It considers strategies for sharing best practices to make sure that different ethical committees, funding assessment committees, reviewers, and regulators have a similar level of awareness regarding the latest scientific advancements in available NAMs. It proposes actions to enhance the confidence of regulators in validated and qualified NAMs. The WG also identifies opportunities for raising awareness among civil society and patients regarding the biomedical research, drug discovery and development process.
The European Commission's Joint Research Centre (JRC) may contribute to the proposal selected for funding, particularly with activities on innovative in vitro biotechnologies.
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Expected results
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:
- 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.
- 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.
- 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.
- 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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Eligibility Criteria
Regions / countries for funding
Faeroes (Føroyar / Færøerne), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Liechtenstein, Norway (Norge), Switzerland (Schweiz/Suisse/Svizzera), Tunisia (تونس /Tūnis), United Kingdom
eligible entities
EU Body, Education and training institution, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
Yes
Project Partnership
To be eligible for funding, applicants must be established in one of the following countries:
- the Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
- the Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR).
- countries associated to Horizon Europe; Albania, Arab Republic of Egypt, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Republic of Korea, Serbia, Switzerland, Tunisia, Türkiye, Ukraine, United Kingdom. Other third countries may become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.
- 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 may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
Any legal entity, regardless of its place of establishment, including legal entities from non associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call/topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
Unless otherwise provided for in the specific call/topic conditions, only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:
- at least one independent legal entity established in a Member State; and
- at least two other independent legal entities, each established in different Member States or Associated Countries.
As affiliated entities do not sign the grant agreement, they do not count towards the minimum eligibility criteria for consortium composition (if any).
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 may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding. Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner. The JRC will not participate in the preparation and submission of the proposal - see General Annex B.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
other eligibility criteria
Specific cases
Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any specific call/topic conditions.
Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
International organisations — International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
Joint Research Centre (‘JRC’) — Where provided for in the specific call/topic conditions, applicants may include in their proposals the possible contribution of the JRC, but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate either as beneficiaries or as affiliated entities (otherwise their costs will NOT be eligible).
EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity.
Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.). In the case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
Additional Information
Applications must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.
Applications must be complete and contain all parts and mandatory annexes and supporting documents.
Applications must include a plan for the exploitation and dissemination of results including communication activities, unless provided otherwise in the specific call/topic conditions. The plan is not required for applications at the first stage of two-stage procedures. If the expected exploitation of the results entails developing, creating, manufacturing and marketing a product or process, or in creating and providing a service, the plan must include a strategy for such exploitation. If the plan provides for exploitation of the results primarily in non-associated third countries, the applicants must explain how that exploitation is to be considered in the EU’s interest.
The application form will have two parts:
- Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
- Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 45 pages.
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 – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025).
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Call documents
Horizon Europe Work Programme 2026-2027 Cluster 1 - HealthHorizon Europe Work Programme 2026-2027 Cluster 1 - Health(1700kB)
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