Deadline: October 08, 2026
The Innovative Health Initiative (IHI) has launched this funding opportunity to accelerate the development of an Artificial Intelligence Foundation Toxicology Model and a transparent framework that supports scientifically justified waivers for second-species toxicity testing in drug safety studies while promoting safe, efficient, and ethical medicine development.
The opportunity focuses on developing an AI Foundation Toxicology Model, establishing a standardized weight-of-evidence framework, validating AI-driven toxicology predictions, supporting regulatory adoption of New Approach Methodologies (NAMs), reducing reliance on animal testing, improving consistency in safety assessments, enabling second-species waivers for chronic and sub-chronic studies, strengthening regulatory confidence, promoting transparent and explainable AI, enhancing patient safety, supporting sustainable model evolution, and accelerating the development of innovative medicines.
The topic addresses the growing need to modernize nonclinical safety assessments for new medicines by replacing or reducing traditional animal testing with scientifically validated AI-based approaches. It seeks to develop a robust and transparent AI Foundation Toxicology Model capable of predicting whether testing in a second animal species would provide additional safety information during chronic and sub-chronic toxicity studies. The initiative supports the broader adoption of New Approach Methodologies while maintaining high standards of patient safety and regulatory confidence.
Applicants are expected to consolidate and evaluate high-quality toxicology data from pharmaceutical companies and other organizations. This includes structured and unstructured toxicity study data along with other relevant datasets that can strengthen AI model development. The proposal should also establish a secure database that enables collaborative analysis while protecting sensitive information and supporting future regulatory decision-making.
The project should systematically assess existing artificial intelligence approaches and optimize suitable methods capable of delivering transparent probabilistic predictions. The selected AI methodologies should ensure interpretability, traceability, data provenance, and uncertainty estimation while supporting regulatory expectations. Alternative modelling approaches may also be explored if they offer effective solutions.
A major component of the project involves designing, training, and validating the AI Foundation Toxicology Model. The model should generate reliable predictions across different study durations, species, and toxicity outcomes while demonstrating strong performance, robustness, explainability, and trustworthiness. Validation should be carried out through representative use cases with active participation from industry, academic institutions, small and medium-sized enterprises, and regulatory stakeholders.
The proposal must also establish a standardized weight-of-evidence framework that integrates AI model outputs with additional scientific evidence. The framework should provide transparent and reproducible decision-making by evaluating evidence quality, consistency, uncertainty, severity, and human relevance to support regulatory submissions for second-species waivers.
The total indicative budget for this topic is €53.2 million under a two-stage application process. The first-stage application deadline is 8 October 2026, while successful applicants will be invited to submit full proposals by 21 April 2027. The call opened on 2 July 2026. The indicative funding is expected to be approximately €9 million, €9.2 million, and €35 million across the projects supported under this topic.
To ensure long-term impact, applicants should prepare strategies for regulatory adoption, governance, ethical implementation, and sustainable model evolution. The project should include practical tools, implementation guidance, and recommendations that facilitate real-world use of the AI Foundation Toxicology Model while supporting future regulatory developments and broader adoption across the pharmaceutical sector.
The funding opportunity is open to any legal entity regardless of its country of establishment, including organizations from non-associated third countries and international organizations, provided they satisfy the eligibility conditions defined under the Horizon Europe Regulation and the specific topic requirements. Applicants must register in the Participant Register to obtain a Participant Identification Code (PIC) before the grant agreement is signed.
For more information, visit European Commission.
