Guiding Principles of Good AI Practice in Drug Development (FDA and EMA)

Summary

FDA's drug and biologics centres (CDER and CBER) and the European Medicines Agency developed 10 guiding principles that sponsors and product developers can consider when using AI in drug and biological product development. They cover human-centric design, a risk-based approach, adherence to standards, clear context of use, multidisciplinary expertise, data governance and documentation, model design and development, risk-based performance assessment, life-cycle management, and clear essential information. FDA's page is dated January 14, 2026. The principles are not binding.

Key dates

1. January 14, 2026Issued
2. October 16, 2026Checked against sources
3. October 21, 2026Checked against sources

Developments are added when the record is reviewed. Next review: October 16, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

1. CDER and CBER have collaborated with the European Medicines Agency (EMA) to develop 10 guiding principles that industry and product developers can consider when using artificial intelligence (AI)

   Supports: Joint FDA/EMA; 10 principles; non-binding

   Human-centric by design Risk-based approach Adherence to standards Clear context of use Multidisciplinary expertise Data governance and documentation

   Supports: Principle topics

   Content current as of: 01/14/2026

   Supports: Date

   Guiding Principles of Good AI Practice in Drug Development U.S. Food and Drug Administration Primary source