Jurisdiction(s):
European Union

EMA/HMA 2023–2028 AI workplan for EMRN: guidance, LLM tools, collaboration and experimentation towards implementation of the EU AI Act in medicines regulation

Published on: 08 January 2024

Published by a LexisNexis EU Law expert

Legal News

Article summary

On 18 December 2023, the EMA and HMA unveiled their 2023–2028 Multi‑Annual AI Workplan. Designed to support the European Medicines Regulatory Network (EMRN) — a co‑ordinated network of national competent authorities across EEA Member States working with the EMA and the European Commission — the plan encourages adoption of AI for internal regulatory activities and outlines a proposed pathway for regulatory evolution to capture AI’s promise in the medical field. Anticipated gains include higher productivity, automation of repetitive, time‑intensive tasks, and capacity to absorb and utilise far larger data sets in decision‑making.

The Workplan

Acknowledging that health regulators, like the regulated sector, are progressively deploying and building AI‑enabled tools, the Workplan presents a collaborative, co‑ordinated strategy for the coming five years to realise AI’s benefits in medicines regulation, while deliberately identifying and managing the attendant risks. Developed under the guidance of the HMA‑EMA Big Data Steering Group, the Workplan was endorsed by the EMA’s management board at its December 2023 meeting...

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