EU & US Regulatory News (AI in Drug Development – Guiding Principles)
The European Medicines Agency (EMA), in collaboration with the U.S. Food and Drug Administration (FDA, has published Guiding Principles of Good AI Practice in Drug Development (January 2026).
This short but significant document outlines ten core principles to help developers, regulators and stakeholders use artificial intelligence safely and effectively across the entire lifecycle of medicines, from discovery and clinical trials to manufacturing and post-marketing.
🔍Key points:
AI should be human-centric in design, aligning with ethical values and patient safety.
Use a risk-based approach with appropriate validation and oversight relative to context of use.
Ensure adherence to legal, scientific, cybersecurity and ethical standards.
Define a clear context of use when and how AI is intended to support decisions.
Maintain robust data governance, documentation, lifecycle management and performance assessment.
Provide clear, accessible information to users about AI limitations and appropriate use.
📘 Guidance document link:
https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf