In 2026, setting clear AI expectations is the priority. On January 14, 2026, EMA and FDA marked a step towards regulatory alignment by publishing joint guiding principles for good AI practice. These shared expectations establish a common standard on what ‘good’ looks like. The principles inform how AI should support evidence across the lifecycle, including clinical trials and safety monitoring.

Rather than adding new requirements, the principles act as a reference point for how AI should be applied within regulated processes. They remain technology-neutral while being operationally specific, calling for clear definition of context of use, implementation of risk-based controls, governance of data and documentation, and lifecycle management to ensure oversight remains intact.

The focus is no longer just on whether AI can be used, but whether it can be run reliably, transparently and with accountability.