[European Commission](https://commission.europa.eu/index_en)

October 9, 2025 (Stage 1) | April 29, 2026 (Stage 2)

Total budget ~€8,906,000; one project funded; typical duration 3–5 years

Supports development and real-world implementation of AI-driven methods for improved drug safety signal detection and risk prediction in pharmacovigilance.

Legal entities in the UK and Canada are not eligible for funding.

--- ## Description This opportunity, under the Horizon Europe Innovative Health Initiative (IHI), funds research and innovation actions to develop and implement artificial intelligence (AI) methodologies that enhance the speed, accuracy, and scalability of signal detection and risk prediction in pharmacovigilance. The goal is to improve drug safety and patient outcomes by leveraging diverse data sources—including electronic health records, spontaneous reporting systems, social media, and genomics—to identify adverse drug reactions earlier and more effectively. Expected impacts include: - Enhanced drug safety through faster and more accurate signal detection - Proactive risk management and improved patient safety - Greater efficiency and reduced manual workload for healthcare professionals - Evidence to inform future policy and regulatory frameworks regarding AI in pharmacovigilance Funded projects are expected to deliver practical tools, recommendations, and training resources for industry, regulators, and researchers, with a focus on transparency, trustworthiness, and ethical/legal compliance. --- ## Due Dates - Stage 1 (Short Proposal): October 9, 2025, 17:00 Brussels time - Stage 2 (Full Proposal, by invitation): April 29, 2026, 17:00 Brussels time --- ## Funding Amount - Indicative budget for this topic: approximately €8,906,000 - Only one project will be funded - Typical project duration: 3–5 years - Funding covers research, development, pilot testing, recommendations, implementation tools, and dissemination activities --- ## Eligibility - Open to legal entities (universities, research organizations, SMEs, industry, public bodies) established in EU Member States or Horizon Europe Associated Countries. - Legal entities established in the UK and Canada are not eligible for funding under this topic. - Consortia must adhere to standard Horizon Europe eligibility, including minimum partnership requirements. - Participation from both public and private sector stakeholders is encouraged. - Non-EU/non-Associated Country entities may participate as self-funded partners; see [Horizon Europe Programme Guide](https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/programme-guide_horizon_en.pdf) for details. --- ## Application Process - Two-stage submission: - **Stage 1**: Submit a short proposal (max 20 pages) via the [EU Funding & Tenders Portal](https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2025-11-03-two-stage). - **Stage 2**: If invited, submit a full proposal (max 50 pages). - Required documents include: - Part A (generated in submission system) - Part B (short or full proposal template) - Compulsory annexes (e.g., type of participants, budget, in-kind contributions, clinical studies statement if applicable) - Ethics self-assessment - Proposals evaluated on excellence, impact, and quality/efficiency of implementation. - Detailed templates and annexes available on the [IHI JU call documents page](https://www.ihi.europa.eu/apply-funding/call-documents). - For guidance, consult the [IHI JU Guide for Applicants](https://www.ihi.europa.eu/sites/default/files/IHI_Guide_for_Applicants.pdf) and [Online Manual](https://webgate.ec.europa.eu/funding-tenders-opportunities/display/OM/Online+Manual). --- ## Additional Information - The action must focus on AI for signal detection and risk prediction in pharmacovigilance—not on case management or periodic safety reports. - Emphasis on transparency, explainability, data provenance, and regulatory compliance (e.g., ALTAI framework for trustworthy AI). - Engagement with the European Medicines Agency (EMA) and other regulators is expected. - Human-in-the-loop and human-on-the-loop approaches should be addressed. - Proposals should include plans for stakeholder training and dissemination. --- ## External Links - [Call Topic Page (EU Funding & Tenders Portal)](https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2025-11-03-two-stage) - [IHI JU Call 11 Full Topic Text (PDF)](https://www.ihi.europa.eu/sites/default/files/uploads/Documents/Calls/IHI_Call11_CallText.pdf) - [IHI JU Proposal Template (Stage 1, Part B)](https://www.ihi.europa.eu/sites/default/files/IHI_Proposal_template_RIA_SP_PartB.pdf) - [IHI JU Proposal Template (Stage 2, Part B)](https://www.ihi.europa.eu/sites/default/files/uploads/Documents/Calls/IHI_Proposal_template_RIA_FP_PartB_UpdateJan2025.pdf) - [Horizon Europe Work Programme General Annexes](https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/wp-call/2025/wp-14-general-annexes_horizon-2025_en.pdf) - [IHI JU Work Programme 2025](https://www.ihi.europa.eu/sites/default/files/uploads/Documents/About/AWP/WorkProgramme2025_Amend1.pdf) - [IHI JU Guide for Applicants](https://www.ihi.europa.eu/sites/default/files/IHI_Guide_for_Applicants.pdf) - [Partner Search Tool](https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/how-to-participate/partner-search?order=DESC&pageNumber=1&pageSize=50&sortBy=lastModified&isExactMatch=true&type=ORGANISATION,PERSON&frameworkProgramme=43108390) --- ## Contact Information | Purpose | Contact/Resource | |-----------------------------|--------------------------------------------------------------------------------------------------| | General EC Contact | [European Commission Contact Page](https://commission.europa.eu/about-european-commission/contact_en) | | IHI JU Programme Info | [IHI JU Contact](https://www.ihi.europa.eu/about/contact-us) | | IT/Portal Helpdesk | [Funding & Tenders Portal IT Helpdesk](https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/support/helpdesks/contact-form) | | National Contact Points | [NCP Directory](https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/support/ncp) | | Research Enquiry Service | [Research Enquiry Service](https://research-and-innovation.ec.europa.eu/contact-us/research-enquiry-service_en) | ---

AI-Powered Signal Detection in Pharmacovigilance

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