AI is officially under joint regulatory scrutiny, on both sides of the Atlantic.
On January 14, 2026, the EMA and FDA jointly published the “Guiding Principles of Good AI Practice in Drug Development.”
For the first time, the two agencies aligned on a common baseline for how AI should be governed across the medicine lifecycle.
The framework outlines 10 high-level principles covering AI use from early discovery and clinical trials to manufacturing and post-market safety monitoring.
What regulators expect is clear:
- Human oversight of AI-supported decisions
- Risk-proportionate controls
- Transparency and traceability
- Documented data provenance
- Robust lifecycle management
These principles are not a new regulation, but they signal how future submissions will be evaluated.
For companies developing AI-enabled drugs, tools, or evidence pipelines, governance is becoming part of regulatory readiness.
Swiss companies should pay particular attention: even without country-specific AI guidance, alignment pressure from EMA and FDA expectations will directly shape global submissions and review interactions.
Organizations that build structured AI governance frameworks now will be far better positioned when it does.
confinis supports MedTech and pharma leaders in designing AI governance strategies aligned with major regulatory authorities worldwide. Get in touch!
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