EMA and FDA establish common principles for AI in drug development

The new transatlantic framework establishes ten basic standards to ensure the ethical and safe use of artificial intelligence throughout the pharmaceutical life cycle.

Amsterdam/Washington, January 15, 2026 – The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have announced a landmark collaboration, identifying ten principles for good practices in the field of artificial intelligence (AI) in the drug life cycle. This initiative aims to align regulatory approaches on both sides of the Atlantic as AI becomes increasingly integrated into drug development, from discovery to post-marketing safety.

In brief

EMA and FDA have agreed on ten guiding principles for the use of AI in drug development.

The guidelines cover all stages, from early research and clinical trials to manufacturing and safety monitoring.

Commissioner Olivér Várhelyi welcomed the agreement as a key step in EU-U.S. cooperation to maintain supremacy in global innovation while ensuring patient safety at the same time.

The newly established principles provide broad guidance for pharmaceutical developers, marketing authorization applicants, and their holders. They are designed to serve as a foundation for future AI guidelines in both jurisdictions and to facilitate enhanced international collaboration between regulatory authorities and standard-setting organizations. The scope is comprehensive, addressing the application of AI in evidence generation and monitoring across all phases of a drug's life, including early research, clinical trials, and manufacturing.

The European Commissioner for Health and Food Safety, Olivér Várhelyi, described the initiative as "a first step in renewed EU-U.S. cooperation in the field of new medical technologies." He emphasized that the principles demonstrate how the two sides of the Atlantic can work together to "maintain our leadership role in the global race for innovation, while ensuring at the same time the highest level of patient safety."

The measure comes in the context of the significant increase in the use of AI technologies in the sector. As highlighted in the European Commission's proposal on the Biotechnology Act, AI has the potential to accelerate the path from innovation to effective treatments. However, regulatory authorities emphasize that these benefits must be balanced with expert management to mitigate risks. This principle-based approach aligns with the strategy of the European Medicines Agencies Network (EMANS) through 2028 and with the joint work plan on Data and AI, prioritizing ethics and global convergence to facilitate responsible innovation.

https://2eu.brussels/ro/stiri/ema-si-fda-stabilesc-principii-comune-pentru-ia-in-dezvoltarea-medicamentelor