EMA and HMA Mark a Key Step with 1st AI Observatory Report
The European Medicines Agency (EMA) recently shared a post on LinkedIn:
”The first AI Observatory report by EMA and the Heads of Medicines Agencies (HMA) summarises the experience gained in hashtag Artificial Intelligence across the EU medicines regulatory network in 2024. The report includes a high-level horizon scanning to identify gaps, challenges and opportunities for integrating AI in medicines regulation.
Key observations:
- AI is increasingly being used through the medicine’s lifecycle, especially in the pre-authorisation stage, with a broad scope of applications to gain insights and support decision making
- By 2024, EMA had been involved in 7 processes to qualify AI tools for medicine development and in 4 scientific advice procedures related to AI
- The network plans to use AI to automate processes and enhance systems or personal productivity – 27 AI tools were reported in 2024, of which 14 were from national agencies.
The AI Observatory was launched as part of the multi-annual AI workplan by the HMA-EMA Network Data Steering Group. The aim is to leverage safe and responsible use of AI for the benefit of public and animal health in the EU.”
The EMA and Heads of Medicines Agencies (HMA) have released their first AI Observatory report, summarizing AI use in the EU medicines regulatory network in 2024.
AI is increasingly applied in medicine development, especially before authorisation, with EMA engaging in 7 AI qualification and 4 scientific advice procedures last year.
The network reported 27 AI tools, including 14 from national agencies, to automate processes and enhance productivity.
The Observatory, part of the HMA-EMA AI workplan, aims to ensure the safe and responsible use of AI in medicines regulation.
Hemostasis Today: Your Daily Brief on Key Medical Developments.
-
Aug 26, 2026, 17:46Bruno Pougault: The Hidden Burden of Hemostatic Disorders in Women
-
Aug 26, 2026, 17:39Charan Gubba: Adult ITP – A major shift in the 2026 ASH Guidelines
-
Aug 26, 2026, 17:38Stephan A Mayer: Early Imaging Reveals Higher Risk of Hematoma Expansion After ICH
-
Aug 26, 2026, 17:09Kemal Karaagac: NOACs May Offer Cognitive and Clinical Benefits in AF With Alzheimer’s Disease
-
Aug 26, 2026, 16:53Chokri Ben Lamine: Antiphospholipid Syndrome After Kidney Transplantation
-
Aug 26, 2026, 16:32Kai Rejeski: Why TP53 Mutations May Define a Higher-Risk CAR-T Population
-
Aug 26, 2026, 16:20Ons Marsit: Impact of Electroanatomical Mapping on Pentaspline Pulsed Field Ablation
-
Aug 26, 2026, 16:18Sam Mbunya: Celebrating Cyrus Njuguna Githinji’s New Leadership Role in Haemophilia Care
-
Aug 26, 2026, 15:48Melissa Hollo: Postpartum Depression is More Than the “Baby Blues”