EMA and the FDA have jointly identified 10 principles for good artificial intelligence practice in the medicines lifecycle.
The use of AI technologies across the medicines lifecycle has increased significantly in recent years and holds great promise as a tool to accelerate the path from innovation to safe and effective medicines.
As AI continues to evolve, a principles-based approach will help regulators, pharmaceutical companies and medicines developers harness the potential of these technologies while ensuring patient and animal safety and regulatory compliance.
This EMA-FDA initiative builds on collaborative work and aligns with EMA’s mission to promote safe and responsible use of AI.
Check out the 10 guiding principles below. For more details

