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.
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