About

The Innovative Health Initiative (IHI) has launched this funding opportunity to accelerate the development of an Artificial Intelligence Foundation Toxicology Model (AI-FTM) and a transparent weight-of-evidence framework that supports scientifically justified waivers for second-species toxicity testing in drug safety studies. The program aims to modernize nonclinical safety assessments by reducing reliance on animal testing, validating AI-driven toxicology predictions, and supporting regulatory adoption of New Approach Methodologies (NAMs).

Projects funded under this call are expected to design, train, and validate robust AI models capable of predicting whether testing in a second animal species provides additional safety information in chronic and sub-chronic studies. Activities include consolidating high-quality toxicology data, establishing secure collaborative databases, optimizing AI methodologies for transparency and interpretability, and developing standardized frameworks for regulatory submissions. The initiative emphasizes patient safety, regulatory confidence, ethical implementation, and sustainable model evolution.

The total indicative budget is €53.2 million, with funding distributed across projects at approximately €9 million, €9.2 million, and €35 million. Grants will support multi-stakeholder collaborations involving industry, academia, SMEs, and regulatory bodies. The call opened on 2 July 2026, with a two-stage application process: first-stage proposals are due by 8 October 2026, and full proposals by 21 April 2027. Supported projects are expected to deliver practical tools, guidance, and recommendations that enable real-world adoption of AI-based toxicology models across the pharmaceutical sector.

Eligibility

This funding opportunity is open to any legal entity, regardless of country of establishment, including organizations from non-associated third countries and international organizations, provided they meet the eligibility conditions defined under the Horizon Europe Regulation and the specific topic requirements. Applicants must register in the Participant Register and obtain a Participant Identification Code (PIC) before signing the grant agreement. Proposals will be evaluated based on scientific excellence, data quality, methodological transparency, regulatory relevance, and potential impact on patient safety and ethical medicine development.

Post Date: July 06, 2026