SESSIONE XIII - QUALITÀ
Current Updates and News around EU GMP Annex 22 - AI
ABSTRACT:
-/- English Session - Online -/- Artificial intelligence is rapidly transforming pharmaceutical quality systems, and Annex 22 emerges as the EU’s attempt to regulate this shift. AI behaves fundamentally differently from traditional software, creating challenges for reproducibility, validation, and GMP expectations. The EU AI regulation introduces extensive obligations for high‑risk and other AIs, many of which directly overlap with Annex 11 requirements for documentation, risk management, and human oversight. At the same time, the regulatory process behind Annex 22 (current draft version) raises major concerns: the annex did not appear in the EMA Inspectors Working Group’s work plan, information circulates unofficially for months, and publication occurs only after external pressure, leaving industry without clear guidance. The draft versions of Annex 11 and Annex 22 expand dramatically in scope and detail, affecting negatively thousands of companies and requiring significant updates to procedures and training without added value. The presentation argues that AI forces a fundamental regulatory rethink, while the path toward clarity remains inconsistent and politically influenced, making early preparation essential.
The presentation also outlines EMA’s future plans for AI‑related regulation, showing how the agency intends to separate fast‑moving AI topics from traditional computerized system guidance.
