Description

The IHI Call 13 is a two-stage Research and Innovation Action (RIA) under the Innovative Health Initiative Joint Undertaking (IHI JU). The call aims to accelerate healthcare innovation through collaborative public-private research addressing major health challenges. It includes three topics: (1) establishing a European healthcare innovation network, (2) developing AI-based toxicology models to reduce animal testing in drug safety studies, and (3) advancing understanding of immune-mediated diseases associated with ageing.

This topic aims to develop and validate an Artificial Intelligence (AI) Foundation Toxicology Model and a standardised weight-of-evidence framework to support regulatory decisions on waiving second-species chronic and sub-chronic toxicity studies for small molecule medicines. The project seeks to accelerate the adoption of New Approach Methodologies (NAMs), reduce reliance on animal testing, improve regulatory consistency, and enable faster, more cost-effective drug development while maintaining patient safety. The AI model should be capable of generating transparent probabilistic predictions based on large, harmonised toxicology datasets and should be designed for future extension to additional therapeutic modalities beyond small molecules.

Funding Amount

Maximum IHI JU contribution

• EUR 9,000,000

Additional indicative contributions

• Industry in-kind contribution: EUR 7,300,000
• IHI JU contributing partner (in-kind): EUR 100,000

There is one collaborative project expected under this topic, with the full budget supporting a single consortium. The indicative project duration is 60 months.

Submission Deadlines

• Stage 1 (Short Proposal): 8 October 2026
• Stage 2 (Full Proposal): 21 April 2027 (by invitation only)

Eligible Types of Businesses

Consortia may include organisations eligible under Horizon Europe and IHI Joint Undertaking rules, including:

• SMEs
• Large pharmaceutical companies
• Biotechnology companies
• Universities
• Research institutes
• Hospitals
• Contract research organisations (CROs)
• AI and data science organisations
• Technology providers
• Public bodies
• Non-profit organisations
• Regulatory science organisations

Applicants are expected to collectively provide expertise in:

• toxicology;
• pharmaceutical development;
• AI and machine learning;
• data engineering and federated data platforms;
• regulatory science;
• bioinformatics and computational biology;
• project management of large European public-private partnerships.

Eligible Countries

Participation follows the standard Horizon Europe and IHI JU eligibility rules.

Funding is generally available to legal entities established in:

• EU Member States;
• Horizon Europe Associated Countries;
• other countries eligible under Horizon Europe participation rules.

Country-specific funding restrictions described in the IHI Work Programme apply where relevant.

Submission Conditions

• Research and Innovation Action (RIA).
• Two-stage submission procedure.
• Only the highest-ranked consortium from Stage 1 is normally invited to prepare a full proposal together with the pre-identified industry consortium.
• The full proposal must integrate the pre-identified industry consortium and contributing partner identified in the topic.
• Proposals must be submitted electronically through the EU Funding & Tenders Portal.
• Applicants should demonstrate expertise in AI, toxicology, pharmaceutical safety assessment, federated data management and regulatory science, together with access to appropriate datasets and high-performance computing infrastructure.
• The project should ensure continuous engagement with regulators throughout development and validation to maximise future regulatory acceptance.