EMA and FDA issue joint AI guidance for medicine development

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly proposed ten principles for good artificial intelligence (AI) practice, supporting evidence generation and monitoring for medicines.

The publication aligns with the EMA’s goal of leveraging data, digitalisation and AI and aims to help regulators, pharma companies and drug developers better use the technology across the product lifecycle.

The initiative also follows publication of the FDA’s first guidance on utilising AI for drug development in 2025.

Harnessing AI for more efficient clinical trials

European Commissioner for Health and Animal Welfare Olivér Várhelyi said: “The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies. The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety.”

The principles identified by the EMA and FDA support ongoing development of future EU AI guidance, building on the EMA AI reflection paper published in 2024.

Meanwhile, the existing proposal for the European Commission’s Biotech Act advocates for AI as a promising tool to boost medicine innovation, and the new pharmaceutical legislation accommodates wider use of AI in the medicine lifecycle in regulatory decision-making.

In October, the European Commission unveiled its new AI in Science Strategy, which includes creating a virtual Resource for AI Science in Europe and harnessing AI models and autonomous agentic AI for pharma.

Commenting on the new strategy, Ursula von der Leyen, President of the European Commission, said: “AI adoption needs to be widespread, and with these strategies, we will help speed up the process. Putting AI first also means putting safety first. We will drive this ‘AI first’ mindset across all our key sectors, from robotics to healthcare, energy and automotive.”