Artificial Intelligence Regulation

To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines. The EMA has finalized a reflection paper that underscores a principle-based framework for AI integration across the medicinal product lifecycle. They've also advanced AI tools for regulatory assessors. In parallel, the FDA is navigating AI policy development through a multi-faceted approach, creating specialized groups and an AI Council to address AI’s integration into drug development. As our understanding and use of AI continually shifts one rule of thumb remains constant: The closer AI is to patient care, the more scrutiny it will receive.