The ten regulatory principles aim to support pharmaceutical companies in the generation and monitoring of evidence for new medicines.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly proposed 10 principles for good artificial intelligence (AI) practices to support evidence generation and oversight of medicines.
This publication is in line with EMA’s aim to leverage data, digitization and AI and aims to help regulators, pharmaceutical companies and drug developers make better use of technology across the product lifecycle.
This effort also follows the release of FDA’s first guidance on leveraging AI in drug development in 2025.
Utilizing AI to realize more efficient clinical trials
Oliver Verhelyi, European Commissioner for Health and Animal Welfare, said: “The Guiding Principles for Good AI Practice in Pharmaceutical Development are the first step in new cooperation between the EU and the US in the field of new medical technologies. The Principles are a good example of how we can work together on both sides of the Atlantic to maintain our leading role in the global innovation race while ensuring the highest level of patient safety.”
The Guiding Principles for Good AI Practice in Drug Development are the first step in new EU-US cooperation in the field of new medical technologies. ”
The principles identified by EMA and FDA will support the continued development of future EU AI guidance, building on the EMA AI Reflection Paper published in 2024.
Meanwhile, the European Commission’s existing proposals for biotechnology law advocate AI as a promising tool to foster pharmaceutical innovation, and the new Pharmaceutical Affairs Law addresses the widespread use of AI in the drug lifecycle for regulatory decision-making.
In October, the European Commission published a new AI in Science Strategy. This includes creating virtual resources for AI science in Europe and leveraging AI models and autonomous agent AI for pharmaceuticals.
Commenting on the new strategy, European Commission President Ursula von der Leyen said: “AI adoption needs to be widespread, and with these strategies we will help speed up that process. Putting AI first also means putting safety first. We will drive this ‘AI first’ thinking in all key sectors, from robotics to healthcare, energy and automobiles.”
