CSOAI - pharma + life sciences + EU AI Act
AI in pharma and life sciences and the EU AI Act
Not all pharma AI is high-risk - early-stage drug-discovery models often sit outside Annex III - but AI inside medical devices, clinical decision support, and safety-critical pharmacovigilance can be. GPAI duties for foundation models apply from 2 Aug 2026, and GxP and EMA expectations run in parallel. Here is the honest line.
High-risk uses in your sector
- !AI as a safety component of a medical device (MDR / IVDR overlap)
- !Clinical decision support used in trials or care
- !Safety-signal detection in pharmacovigilance, where safety-critical
- !Note: pure early-stage drug-discovery AI is often not Annex III high-risk
What you must do
- +GPAI transparency and documentation for foundation models (from 2 Aug 2026)
- +Human oversight and validation for device or clinical AI
- +Alignment with GxP and EMA expectations on AI
- +Data governance, bias testing, logging, and traceability
Questions, answered
Often not. Early-stage drug-discovery models are typically not listed in Annex III. AI becomes high-risk when it is a safety component of a medical device or used in clinical decision-making.
Yes. General-purpose AI (GPAI) models carry transparency and documentation duties that apply from 2 August 2026, regardless of sector.
The AI Act sits alongside GxP and EMA expectations on AI. Validation and documentation work can be aligned, but the AI-Act-specific duties for high-risk and GPAI systems are additional.
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