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ARTICLE · 15 JULY 2025

EU Consults On New GMP Rules For AI In Pharma Manufacturing

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On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing.

European UnionTechnology
Alexander Roussanov
Alexander Roussanov
Anna Pothof
Anna Pothof
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On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing Practice (GMP) guidelines—specifically Chapter 4 on Documentation, Annex 11 on Computerised Systems, and, for the first time, a new Annex 22 dedicated to AI.

The proposals reflect regulators' growing recognition that AI is rapidly becoming part of the pharmaceutical manufacturing landscape. From process optimisation to quality control, AI is expected to bring efficiency and insights that traditional systems can't always deliver. Yet the European Medicines Agency ("EMA") and the Euroean Commission are aware that these same technologies also potentially bring new risks (which may, to an extent, be unforeseeable) —especially when it comes to patient safety, product quality, and data integrity.

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