Atlas Live · EMEA edition
The live atlas — what is open and what has been enforced
Open consultations and recent enforcement actions across the ten published sectors. Sorted so the next deadline is at the top and the most recent action is most visible. Sources cited inline.
Feed source · editorial seed · Refreshed
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Open consultations · sorted by deadline
2 open
| Deadline | Sector | Regulator | Jurisdiction | Consultation |
|---|---|---|---|---|
| Pharma | FDA & MHRA — GxP AI/ML | UK, EU & US | FDA draft guidance — AI/ML lifecycle management within 21 CFR Part 11 boundaries | |
| Pharma | FDA & MHRA — GxP AI/ML | UK, EU & US | EMA reflection paper update — AI in the pharmaceutical lifecycle |
Recent enforcement actions · sorted most-recent first
1 actions
| Date | Sector | Regulator | Target | Summary |
|---|---|---|---|---|
| Pharma | FDA & MHRA — GxP AI/ML | Tier-1 European biopharma — GxP validation AI | MHRA inspection finding: an AI tool used in GxP batch-release decisions lacked an Annex 11 validation file and a current OQ/PQ evidence pack. |
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