EMA and FDA set AI principles for medicine

Regulators outline key principles for AI in medicine, aiming to balance innovation, patient safety, and international collaboration.

EMA and FDA have established ten guiding principles to ensure artificial intelligence is used safely and effectively across the entire medicines lifecycle.

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have released ten principles for good AI practice in the medicines lifecycle. The guidelines provide broad direction for AI use in research, clinical trials, manufacturing, and safety monitoring.

The principles are relevant to pharmaceutical developers, marketing authorisation applicants, and holders, and will form the basis for future AI guidance in different jurisdictions. EU guideline development is already underway, building on EMA’s 2024 AI reflection paper.

European Commissioner Olivér Várhelyi said the initiative demonstrates renewed EU-US cooperation and commitment to global innovation while maintaining patient safety.

AI adoption in medicine has grown rapidly in recent years. New pharmaceutical legislation and proposals, such as the European Commission’s Biotech Act, highlight AI’s potential to accelerate the development of safe and effective medicine.

A principles-based approach is seen as essential to manage risks while promoting innovation.

The EMA-FDA collaboration builds on prior bilateral work and aligns with EMA’s strategy to leverage data, digitalisation, and AI. Ethics and safety remain central, with a focus on international cooperation to enable responsible innovation in healthcare globally.

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