European Medicines Agency and the Food and Drug Administration

The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have jointly developed basic guidelines for the use of artificial intelligence in drug development, covering stages from clinical trials to safety monitoring. The principles should be of interest not only to drug developers, but also to responsible entities – both those holding a marketing authorisation for a medicinal product and those applying for one. The 10 principles include:
 

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 practices;
8. Risk-based performance assessment;
9. Life cycle management;
10. Clear, essential information.
 

The cooperation between the EMA and the FDA is the result of a meeting in April 2024 and is also part of the EMA's efforts to support the responsible development of innovation, including the use of artificial intelligence.