The US FDA and EMA collaborate on a risk-based AI governance framework to harmonize oversight of AI-driven drug discovery, clinical trials, and manufacturing, ensuring safety, efficacy, and ethical deployment of emerging technologies.
Key points
- FDA’s AI Steering Committee aligns over 20 AI use cases across agency offices under a unified risk-based evaluation.
- EMA’s 2023–2028 AI work plan focuses on guidance, policy, tool development, and personnel training for medicines regulation.
- Recommendations include legislative updates, global harmonization via ICH, capacity building, and leveraging digital twins and SaMD oversight.
Why it matters: A unified AI governance framework streamlines drug development, mitigates regulatory fragmentation, and maintains high safety standards for AI-driven therapeutics.
Q&A
- What is a risk-based AI governance framework?
- How does the AI Steering Committee (AISC) coordinate initiatives?
- What are digital twins in therapeutics?
- Why is global harmonization of AI regulations important?