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

Date

January 14, 2026

Category

US Regulations

Description

FDA’s 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) to advance drug and biological product development.; see Guiding Principles of Good AI Practise in Drug Development | FDA

To fully realise the potential of AI while ensuring reliability of the information to ensure patient safety and regulatory excellence, it is essential to establish guiding principles that address the unique challenges and considerations of AI applications in drug development.

The 10 principles are tailored to the drug development cycle and emphasise the importance of:

1. Human-centric by design
2. Risk-based approach
3. Adherence to standards
4. Clear context of use
5. Multidisciplinary expertise
6. Data governance and documentation
7. Model design and development practises
8. Risk-based performance assessment
9. Life cycle management
10. Clear, essential information