FDA and EMA guiding principles for good AI practice in drug development

After several months of collaboration, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a common set of 10 guiding principles to inform, enhance, and promote the use of artificial intelligence (AI) for generating evidence across all phases of the drug product life cycle.

The integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving health care. AI technologies are anticipated to help promote innovation, reduce time-to-market, strengthen regulatory excellence and pharmacovigilance, and decrease reliance on animal testing by improving the prediction of toxicity and efficacy in humans.

These 10 guiding principles lay the foundation for developing good practice that addresses the unique nature of these technologies and identifies areas for potential collaboration by international regulators, international standards organizations and other collaborative bodies.