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An AI Foundation Toxicology Model and Framework to Support Waiving a Second Species in Drug Safety Studies

European Commission · Horizon Europe Framework Programme (HORIZON)

Posted 2 Jul 2026 · 7 days left

In plain terms

The European Commission's Innovative Health Initiative Joint Undertaking funds research to develop an AI-driven toxicology model to support waiving second-species animal testing in drug safety studies, with grants from 9 to 35 million euros. Applicants from EU, associated countries, and partners from Canada, Switzerland, the UK, and South Korea may apply in English by 8 October 2026.

A generated summary of the donor's text; the original wording is below.

Summary

Expected Impact:

The action under this topic is expected to achieve the following impacts:

Faster and more informed decision-making through the use of an AI-driven NAM (AI Foundation Toxicology Model) and increased efficiency through rapid processing of vast amounts of data [1].

Increased consistency and standardisation in a NAM-based approach, specifically an AI model, used by industry in the efficient development, testing and production of safe and effective innovative health technologies, improving industrial competitiveness.

Regulatory adoption of a NAM-enabled second species waiver model (AI Foundation Toxicology Model) and weight-of-evidence framework, in line with recommendations and more consistent global decision-making on waiving second species testing.

Reduction in animal use, accelerated timelines and lower costs, enhancing the competitiveness of the European health industry through economical and ethical benefits.

Improved public health as patients will benefit from safe and effective medicines developed faster using validated NAMs.

The action is expected to contribute to the EU Directive (2010/63/EU) [2] on the protection of animals used for scientific purposes and…

Excerpt from the donor's page. The full text, annexes and forms are on the original call.

Eligible regions

eu_only

Who can apply

ngo_cso
academia_research
private_company
government

Eligibility and conditions

Show the eligibility text from the source

">General conditions

1. Admissibility conditions: Proposal page limit and layout

described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System :

at the first stage of a two-stage call, the limit for RIA short proposals is 20 pages;

at the second stage of a two-stage call, the limit for RIA full proposals is 50 pages.

2. Eligible countries

described in Annex B of the Work Programme General Annexes.

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. See the information in the Horizon Europe Programme Guide.

3. Other Eligibility Conditions

described in Annex B of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)

4. Financial and operational capacity and exclusion

described in Annex C of the Work Programme General Annexes.

5a. Evaluation and award: Award criteria, scoring and thresholds

described in Annex D of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)

5b. Evaluation and award: Submission and evaluation processes

described in Annex F of the Work Programme General Annexes and the Online Manual.

5c. Evaluation and award: Indicative timeline for evaluation and grant agreement

described in Annex F of the Work Programme General Annexes.

6. Legal and financial set-up of the grants

described in Annex G of the Work Programme General Annexes.

Specific conditions

described in the ''Conditions of the Calls for proposals and Calls management rules'' section of the the IHI JU Work Programme (WP)

specific conditions on Availability, Accessibility and Affordability (3A) do not apply to this topic

JU's right to object to transfer/exclusive licensing

Information on eligibility for funding : Legal entities based in all countries associated to Horizon Europe, including Canada, Switzerland, the UK, and South Korea, will be eligible to receive funding under this call, in line with the normal rules.

Where relevant, templates of the reference documents and associated guidance can be found on the IHI JU website.

Regarding the application forms for submitting proposals, the relevant templates and annexes are available to download in the submission system of the Funding and Tender Opportunities portal.

The IHI JU 13th Call for proposals full topics text is available here.

Application and evaluation forms and model grant agreement (MGA):

Application form templates — the application form specific to this call is available in the Submission System

Evaluation form (RIA Actions – single and two-stage Calls procedure)

IHI JU Evaluation form for Research and Innovation Actions

Proposal Templates Part A and Part B (RIA Actions – single and second stage of two-stage procedure)

1. For 1st stage of two-stage calls

Proposal template - Part A : Part A of the proposal is generated by the IT system in the submission system, where applicants insert general information on their short proposal (e.g. proposal acronym), details of the participants, and the budget. For more information, see the Horizon Europe Stage 1 Part A template here. (Note that only Part A of this template applies to this call. For Part B, see below.)

Proposal template - Part B : IHI JU Proposal (RIA/SP) - PART B

Proposal Annex: Annex : Type of participants

Compulsory annex for Short proposals. The “type of participants” is an IHI specific annex related to Short proposals (first stage of two-stage calls). It can be found here. Instructions on how to fill in this template can be found here.

2. For 2nd stage of two-stage calls

Proposal template - Part A : Part A of the proposal is generated by the IT system…