What’s changing in AI regulation for drug development
Regulatory experts from Veeva Systems share how life sciences organisations are turning their focus from experimentation to building AI that stands up to regulatory scrutiny.
On 14 January, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) published joint guiding principles for good AI practice in drug development. This signals regulatory alignment on what ‘good’ looks like when AI supports evidence across the lifecycle, including clinical trials and safety monitoring.
The principles are not a new rulebook, but a reference point for how AI should be applied inside regulated processes. Guidelines are technology-neutral but operationally specific: define the context of use, apply risk-based controls, govern data and documentation, and manage the system across its lifecycle so oversight remains intact. They facilitate the shift from ‘can we use AI?’ to
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