Summary
European Medicines Agency reflection paper setting expectations for use of AI/ML across the medicines lifecycle – R&D, clinical trials, manufacturing, and post‑authorisation. Addresses governance, data quality, validation, GxP alignment, and human oversight; provides considerations for submissions and inspections.
Healthcare Implications
Sponsors using AI in trial design, data analysis, pharmacovigilance, or manufacturing should plan transparent methods, validation packages, and risk management. Clinicians participating in trials may see AI‑enabled tools subject to additional documentation and controls.