Pharmaceutical; Regulatory Affairs · medium ·
Pharma Regulatory Submissions Moving Toward AI Governance And Audit Trails As Gold Standard
Pharmaceutical companies will face increasing regulatory scrutiny on AI use, particularly for systems impacting drug quality and clinical trial results. The EMA will require detailed AI model architecture and validation records in trial protocols, while the EU AI Act's high-risk provisions will apply to critical pharma AI systems from mid-2026. This necessitates robust AI governance, audit trails, and validation evidence packages, akin to regulating AI agents as staff.
Part of the Healthcare & Life Sciences Opportunity Outlook, Korim's monthly analysis of emerging opportunities in this sector.