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4d ago

EMA and FDA Unveil Joint Principles for AI in Drug Development

The move signals a shared push to harness AI in drug development with guardrails for safety.

The FDA and EMA's guidance on best practices for the use of AI in drug development recommend high-quality, compliant models underpinned by relevant and accessible data. Image credit: Visual Generation via Shutterstock.com.
The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo

Overview

  • The high-level guidance outlines good AI practice across discovery, clinical trials, manufacturing, and safety surveillance.
  • Regulators say the principles aim to accelerate innovation while safeguarding patients and ensuring compliance.
  • EMA plans further EU guidance that will align with forthcoming medicines legislation and evolve over time.
  • The initiative builds on EU–US collaboration, including a 2024 bilateral meeting and the EMANS strategy to 2028.
  • The FDA uses a generative AI tool called Elsa, and industry momentum continues with AstraZeneca buying Modella AI and Nvidia and Eli Lilly committing $1 billion to a joint lab.