What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

Why the EMA–FDA AI Principles Signal a New Era in Drug Development The EMA and FDA’s joint publication of 10 guiding principles for the use of AI across the medicines lifecycle marks an important moment for global drug development. These principles signal a clear step forward to help guide industry in terms of how sponsors design trials, manage data, and interact with regulators in both jurisdictions. AI is now becoming part of core regulatory thinking, and sponsors will increasingly be expected