EMA and FDA set common principles for AI in medicine development

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The EMA and FDA have jointly released ten guiding principles for ethical and safe AI implementation in all phases of medicine development, from research to monitoring.

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have collaboratively established ten guiding principles for good artificial intelligence (AI) practices throughout the lifecycle of medicines. These principles aim to provide comprehensive guidance on the application of AI in all stages of medicine development, including early research, clinical trials, manufacturing, and post-market safety monitoring. They are designed to support medicine developers, marketing authorization applicants, and holders, while also fostering international cooperation among regulatory bodies and stakeholders. This initiative is a continuation of prior FDA-EU bilateral discussions and the EMA's 2024 AI reflection paper, emphasizing the potential of AI to expedite the development of safe and effective medicines and mitigate associated risks.

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