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Translating Disruptive New Approach Methodologies (NAMs) into Practice is sponsored by European Commission — Horizon Europe. Expected Impact: This Challenge supports ambitions to maintain and strengthen the health sector in Europe. It will: Accelerate the development and validation of disruptive NAMs for biomedical applications, including medicinal products and medical technologies Support regulatory innovation by providing evidence-based recommendations for the assessment of safety, efficacy, and quality of human health products using NAMs. Enable citizens to benefit from novel technologies that have been assessed through rigorous NAMs that have been validated to can predict potential effects in humans, and Provide industry with a harmonised and standardised NAM-based assessment toolkit that is faster and more flexible. Objective: Specific Objectives This is a two-stage Challenge competition with the ultimate ambition to deliver robust, validated NAMs that constitute a representative model or prototype system i.e. achieve TRL 6 after Stage 2. Applicants should apply to Stage 1 only where there is an outlook of the potential impact in the longer term. Stage 1 – Solution validation and benchmarking Applicants should: Take forward preliminary engagement with regulatory authorities, notified bodies and industry stakeholders Map regulatory, clinical, standardisation (where applicable) and industrial needs, and use this to develop a roadmap for adoption Develop a methodology for performance assessment Deliver small-scale feasibility experiments or modelling Conduct initial performance benchmarking (human relevance, reproducibility, transferability of the approach) Assess ethical, data governance and scalability considerations, as applicable to the given NAM under development. The following milestones need to be achieved at the end of Stage 1: Evidence that the NAM is viable for human relevant biomedical innovation, and addresses the needs of the identified use cases, and Clear commitment from industrial end-users and a well-defined regulatory plan to further develop the NAM in Stage 2. Progress to Stage 2 will be contingent on delivering a full proposal which will be assessed alongside the milestones achieved under Stage 1. Stage 2 – Development and user testing Applicants selected for Stage 2 will further develop and validate a functional, scalable NAM prototype ready for regulatory, industrial, or clinical uptake. Activities must cover a number of the following elements: Benchmarking the NAMs against state-of-the-art animal models and/or human trials Demonstration in relevant application, such as disease modelling, or testing of medicinal products and medical technologies for safety, efficacy, or quality Organisation of consultation meetings/workshops with industrial end users, regulators, CROs (Contract Research Organisations), standard setting bodies or other relevant stakeholders to gather further needs and feedback Engagement with infrastructures for testing and data collection as testing and validation of the NAM outside the developer’s lab Development of regulatory-grade data packages suitable for submission to relevant agencies (e.g. EMA, FDA, OECD), and Documentation on scalability, standardisation, and potential barriers to uptake. During the project’s implementation phase, beneficiaries will be encouraged to consider using the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the European Commission’s Joint Research Centre for aspects of standardisation, automation and validation of in vitro methods. These facilities operate and provide support at the interface between pre-normative research, regulatory sciences and innovation. Scope: New Approach Methodologies (NAMs) have the potential to replace, reduce or refine animal use in the testing96 of medicinal products. Scientific progress in recent decades has delivered several animal-free NAMs that have the potential to transform how we understand human biology and assess the safety, efficacy, and quality testing in the health sector. However, a lack of knowledge, experi
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EU Funding & Tenders Portal EU Funding & Tenders Portal * Results & Innovation support * SME Self-assessment tool Home Funding Calls for proposals Translating Disruptive New Approach Methodologies (NAMs) into Practice Translating Disruptive New Approach Methodologies (NAMs) into Practice * Conditions and documents EIC Advanced Innovation Challenge (HORIZON-EIC-2026-AIC) HORIZON-EIC HORIZON EIC Grants HORIZON Lump Sum Grant [HORIZON-AG-LS] 26 February 2026 17:00:00 Brussels time This Challenge supports ambitions to maintain and strengthen the health sector in Europe.
It will: * Accelerate the development and validation of disruptive NAMs for biomedical applications, including medicinal products and medical technologies * Support regulatory innovation by providing evidence-based recommendations for the assessment of safety, efficacy, and quality of human health products using NAMs.
* Enable citizens to benefit from novel technologies that have been assessed through rigorous NAMs that have been validated to can predict potential effects in humans, and * Provide industry with a harmonised and standardised NAM-based assessment toolkit that is faster and more flexible.
This is a two-stage Challenge competition with the ultimate ambition to deliver robust, validated NAMs that constitute a representative model or prototype system i. e. achieve TRL 6 after Stage 2.
Applicants should apply to Stage 1 only where there is an outlook of the potential impact in the longer term.
**Stage 1 – Solution validation and benchmarking** * Take forward preliminary engagement with regulatory authorities, notified bodies and industry stakeholders * Map regulatory, clinical, standardisation (where applicable) and industrial needs, and use this to develop a roadmap for adoption * Develop a methodology for performance assessment * Deliver small-scale feasibility experiments or modelling * Conduct initial performance benchmarking (human relevance, reproducibility, transferability of the approach) * Assess ethical, data governance and scalability considerations, as applicable to the given NAM under development.
The following milestones need to be achieved at the end of Stage 1: * Evidence that the NAM is viable for human relevant biomedical innovation, and addresses the needs of the identified use cases, and * Clear commitment from industrial end-users and a well-defined regulatory plan to further develop the NAM in Stage 2.
Based on current listing details, eligibility includes: Open to legal entities established in EU Member States and countries associated to Horizon Europe (including EEA/EFTA countries, and other associated third countries). Action type: HORIZON-EIC HORIZON EIC Grants. Additional conditions: "> General conditions 1. Admissibility Conditions: Proposal page limit and layout The call is open for submission by A single legal entity established in a Member State or an Associated Country (‘mono-beneficiary’) if you are a start-up, SME or research performing organisation (university, research or technology organisation, including teams, individual Principal Investigators and inventors). Larger companies (i.e. which do not qualify as SMEs) are not eligible to apply as a single legal... See the official call documentation on the F&T Portal for full eligibility criteria and participation rules. Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates €12M total budget (~$13M USD) ; up to €300K per project ; ~10 grants expected Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
The current target date is February 26, 2026. Build your timeline backwards from this date to cover registrations, approvals, attachments, and final submission checks.
This funding opportunity seeks to enhance operations of a Novel Psychoactive Substance Discovery, Education, and Reporting Institute (NPS Discovery) to rapidly identify and report newly emerging opioids, stimulants, and other drugs which may cause intoxication, impairment, or other adverse effects. Funding Opportunity Number: O-NIJ-2025-172538. Assistance Listing: 16.560. Funding Instrument: CA. Category: ST. Award Amount: Up to $2M per award.
Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3) is sponsored by National Institute on Drug Abuse. Supports high-impact research on the discovery and development of medications, devices, and digital therapeutics to prevent and treat substance use disorders and overdose. Application snapshot: target deadline February 26, 2026; published funding information Varies by project; eligibility guidance Universities, nonprofits, small businesses, and state/local governments. Use the official notice and source links for final requirements, attachment checklists, allowable costs, and submission instructions before applying.
Programme areas: Additional EIC activities, The European Innovation Council (EIC), Innovative Europe
Official opportunity description and requirements excerpt:
EU Funding & Tenders Portal EU Funding & Tenders Portal * Results & Innovation support * SME Self-assessment tool Home Funding Calls for proposals Translating Disruptive New Approach Methodologies (NAMs) into Practice Translating Disruptive New Approach Methodologies (NAMs) into Practice * Conditions and documents EIC Advanced Innovation Challenge (HORIZON-EIC-2026-AIC) HORIZON-EIC HORIZON EIC Grants HORIZON Lump Sum Grant [HORIZON-AG-LS] 26 February 2026 17:00:00 Brussels time This Challenge supports ambitions to maintain and strengthen the health sector in Europe. It will: * Accelerate the development and validation of disruptive NAMs for biomedical applications, including medicinal products and medical technologies * Support regulatory innovation by providing evidence-based recommendations for the assessment of safety, efficacy, and quality of human health products using NAMs. * Enable citizens to benefit from novel technologies that have been assessed through rigorous NAMs that have been validated to can predict potential effects in humans, and * Provide industry with a harmonised and standardised NAM-based assessment toolkit that is faster and more flexible. This is a two-stage Challenge competition with the ultimate ambition to deliver robust, validated NAMs that constitute a representative model or prototype system i.e. achieve TRL 6 after Stage 2. Applicants should apply to Stage 1 only where there is an outlook of the potential impact in the longer term. **Stage 1 – Solution validation and benchmarking** * Take forward preliminary engagement with regulatory authorities, notified bodies and industry stakeholders * Map regulatory, clinical, standardisation (where applicable) and industrial needs, and use this to develop a roadmap for adoption * Develop a methodology for performance assessment * Deliver small-scale feasibility experiments or modelling * Conduct initial performance benchmarking (human relevance, reproducibility, transferability of the approach) * Assess ethical, data governance and scalability considerations, as applicable to the given NAM under development. The following milestones need to be achieved at the end of Stage 1: * Evidence that the NAM is viable for human relevant biomedical innovation, and addresses the needs of the identified use cases, and * Clear commitment from industrial end-users and a well-defined regulatory plan to further develop the NAM in Stage 2. Progress to Stage 2 will be contingent on delivering a full proposal which will be assessed alongside the milestones achieved under Stage 1. **Stage 2 – Development and user testing** Applicants selected for Stage 2 will further develop and validate a functional, scalable NAM prototype ready for regulatory, industrial, or clinical uptake. Activities must cover a number of the following elements: * Benchmarking the NAMs against state-of-the-art animal models and/or human trials
Application snapshot: target deadline February 26, 2026; published funding information €12M total budget (~$13M USD) ; up to €300K per project ; ~10 grants expected; eligibility guidance Open to legal entities established in EU Member States and countries associated to Horizon Europe (including EEA/EFTA countries, and other associated third countries). Action type: HORIZON-EIC HORIZON EIC Grants. Additional conditions: "> General conditions 1. Admissibility Conditions: Proposal page limit and layout The call is open for submission by A single legal entity established in a Member State or an Associated Country (‘mono-beneficiary’) if you are a start-up, SME or research performing organisation (university, research or technology organisation, including teams, individual Principal Investigators and inventors). Larger companies (i.e. which do not qualify as SMEs) are not eligible to apply as a single legal... See the official call documentation on the F&T Portal for full eligibility criteria and participation rules.
Use the official notice and source links for final requirements, attachment checklists, allowable costs, and submission instructions before applying.
Progress to Stage 2 will be contingent on delivering a full proposal which will be assessed alongside the milestones achieved under Stage 1. **Stage 2 – Development and user testing** Applicants selected for Stage 2 will further develop and validate a functional, scalable NAM prototype ready for regulatory, industrial, or clinical uptake.
Activities must cover a number of the following elements: * Benchmarking the NAMs against state-of-the-art animal models and/or human trials * Demonstration in relevant application, such as disease modelling, or testing of medicinal products and medical technologies for safety, efficacy, or quality * Organisation of consultation meetings/workshops with industrial end users, regulators, CROs (Contract Research Organisations), standard setting bodies or other relevant stakeholders to gather further needs and feedback * Engagement with infrastructures for testing and data collection as testing and validation of the NAM outside the developer’s lab * Development of regulatory-grade data packages suitable for submission to relevant agencies (e.
g. EMA, FDA, OECD), and * Documentation on scalability, standardisation, and potential barriers to uptake. During the project’s implementation phase, beneficiaries will be encouraged to consider using the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the European Commission’s Joint Research Centre for aspects of standardisation, automation and validation of in vitro methods.
These facilities operate and provide support at the interface between pre-normative research, regulatory sciences and innovation. New Approach Methodologies (NAMs) have the potential to replace, reduce or refine animal use in the testing96 of medicinal products.
Scientific progress in recent decades has delivered several animal-free NAMs that have the potential to transform how we understand human biology and assess the safety, efficacy, and quality testing in the health sector. However, a lack of knowledge, experience and confidence in the use of such novel methodologies has limited their adoption by end users, including, for example, industry and regulators.
This Challenge competition therefore looks to accelerate the adoption of NAMs in biomedicine and support companies that want to bring NAMs to the market. Applicants should propose innovative and disruptive NAMs addressing one or both of the following areas: * Preclinical biomedical research * Testing of medicinal products and medical technologies for safety, efficacy, or quality. Human organoids or microphysiological systems (e.
g. organ-on-chip, disease-on-chip), in chemico methods, digital twins, virtual patient simulations, AI-enhanced predictive models, mechanistic or integrated in silico platforms, 3D- advanced human tissue model are in scope.
Applicants to this Challenge call should already have: * Proven the viability of their proposed solution in a lab environment at TRL 4 (lab or in silico); * Have letters of intent of at least one of the following stakeholders: an industrial end-user or regulatory body interested in the proposed project; and * Have access to an appropriate infrastructure to carry out the planned activities in Stage 1 and 2.
Applicants to the HORIZON-EIC-2026-AIC-02 topic should note that, in accordance with the EIC 2026 Work Programme, a letter of intent from an industrial end-user or regulatory body is mandatory. Failure to include the required letter of intent will result in the proposal being declared inadmissible. Where appropriate, multiple letters may be submitted; all letters must be combined into a single PDF document annexed to Proposal Part B.
Ethics self-assessment should be included in proposal part A of the proposal. The character limited in this section of proposal part A is considered to be sufficient for participants to give all necessary information. No ethics annex to proposal part B is needed/possible.
The EIC Work Programme 2026 states that: “Sections 1 to 3 and the cover page of part B of your proposal must consist of a maximum of 11 format A4 pages. ” The application template states the same. There is no explicit need for a cover page.
The application can start with the title of the proposal as per the application template. The EIC FAQs have been updated on 23/01/2026. Please (re)consult the FAQs.
The submission session is now available for: HORIZON-EIC-2026-AIC-01, HORIZON-EIC-2026-AIC-02 Topic conditions and documents #### 1.
Admissibility Conditions: Proposal page limit and layout The call is open for submission by * A single legal entity established in a Member State or an Associated Country (‘mono-beneficiary’) if you are a start-up, SME or research performing organisation (university, research or technology organisation, including teams, individual Principal Investigators and inventors). Larger companies (i. e.
which do not qualify as SMEs) are not eligible to apply as a single legal entity. **Proposal page limits and layout:** described in Part B of the Application Form available in the Submission System. #### 2.
Eligible Countries The list of eligible countries is detailed in Annex 2 of the EIC Work Programme 2026. #### 3. Financial and operational capacity and exclusion Described in Annex 2(C.
Financial and Operational Capacity) of the EIC Work Programme 2026. #### 4. Legal and financial set-up of the grants Please refer to the Model Grant Agreement (MGA) used for EIC actions under Horizon Europe Specific conditions are described in the section IV.
EIC Advanced Innovation Challenges- Pilot of the EIC Work Programme 2026 #### Additional documents: EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme Decision authorising the use of lump sums for the EIC Advanced Innovation Challenges pilot phase 1 actions Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement | Topic | Budget (EUR) - Year : 2026 | Stages | Opening date | Deadline | Contributions | Indicative number of grants | | --- | --- | --- | --- | --- | --- | --- | | HORIZON-EIC-2026-AIC-01 - HORIZON-EIC HORIZON EIC Grants HORIZON-EIC-2026-AIC-02 - HORIZON-EIC HORIZON EIC Grants | 6 000 000 | Single-stage | 03/12/2025 | 26/02/2026 | around 300000 around 300000 | 10 10 | To access the Electronic Submission Service, please click on the submission-button next to the **type of action** and the **type of model grant agreement** that corresponds to your proposal.
You will then be asked to confirm your choice, as it cannot be changed in the submission system. Upon confirmation, you will be linked to the correct entry point. To access existing draft proposals for this topic, please login to the Funding & Tenders Portal and select the My Proposals page of the My Area section.
**Please select the type of your submission:** HORIZON EIC Grants [HORIZON-EIC], HORIZON Lump Sum Grant [HORIZON-AG-LS] Topic Q&As**0** item(s) found Please read carefully all provisions below before the preparation of your application. EIC Frequently Asked Questions – FAQ on the Europen Innovation Council website specific to the Advanced Innovation Challenges topics.
Online Manual is your guide on the procedures from proposal submission to managing your grant. Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe. Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular. National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding. IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues. CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers. Partner Search help you find a partner organisation for your proposal.
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