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

This grant supports the development of a validated AI Foundation Toxicology Model and a weight-of-evidence framework to facilitate the waiver of second species in chronic and sub-chronic drug safety studies for small molecule medicines. The project aims to reduce the reliance on animal testing by leveraging New Approach Methodologies (NAMs) and cutting-edge AI, thus increasing industrial competitiveness, efficiency, regulatory acceptance, and adherence to ethical standards. The grant expects to improve decision-making, regulatory consistency, lower costs, and promote faster development of safe and effective medicines.

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Agency	HORIZON (EU)
Region	EUUKUSAother
Country	N/A
Legal form	Company, NGO, Government organization, Private person, Other
Start date	2 Jul 2026
End date	8 Oct 2026
Max funding	Between 9,000,000 EUR and 35,000,000 EUR per grant action, depending on project scope and topic action.
Budget	53,200,000 EUR (year 2026, topic-wide and subject to allocation across grant actions).
Coverage	Funding rate follows Horizon Europe rules for Research and Innovation Actions. Typically covers up to 100% of eligible costs for participating legal entities, subject to specific eligibility and budget caps per action.

Grant application conditions

Applicant Type	Legal entities (public or private bodies) established in EU Member States or Horizon Europe Associated Countries, including Canada, Switzerland, the United Kingdom, and South Korea.
Proposal Format	Stage 1 (short proposal): maximum 20 pages. Stage 2 (full proposal): maximum 50 pages. See Annex A and E of the Horizon Europe Work Programme General Annexes.
Consortium Requirements	Proposals must involve a consortium with multiple organizations (pharmaceutical companies, regulators, academics, SMEs, and other stakeholders) to ensure wide data access, impact, and implementation.
Eligibility	Eligible countries are detailed in Annex B of the Horizon Europe Work Programme General Annexes. Participants from non-EU/non-Associated Countries may be eligible if specific national provisions exist.
Financial and Operational Capacity	Applicants must demonstrate adequate financial resources and operational capacity, as per Annex C of the Work Programme General Annexes.
Evaluation Criteria	Award criteria, scoring, and thresholds described in Annex D and F of the General Annexes. Includes excellence, impact, and quality/efficiency of the implementation.
Annexes/Documentation	Multiple annexes required: type of participants, budget details, declaration of in-kind contributions, information for clinical studies (if applicable), and potentially ethics annex. See specific templates indicated in the grant documentation.
Budget and Funding	Minimum and maximum EU contributions per topic action as defined in the call documents. Subject to budget caps and scope (see funding details).
Compliance	Applicants must adhere to EU Directive 2010/63/EU (protection of animals used for scientific purposes), the 3Rs principle (Replace, Reduce, Refine), and all relevant regulatory and ethical guidelines.
Documentation	https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2026-13-two-stage-02

Eligible expenses

Evaluation criteria

Business exclusions

Reporting

Application process

Application requirements