EU and US regulators publish Ten Commandments for AI

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published a set of ten principles for the ‘good use’ of artificial intelligence in the lifecycle of medicines.

Amid growing adoption of new AI tools across the industry, the regulators have set out broad guidance on how the technology can be used to generate evidence, manufacture products and monitor safety.

The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders, the regulators said in a joint statement. They will underpin future AI guidance in both jurisdictions and support enhanced international collaboration. The development of formal guidelines in the EU is already underway, building on the EMA AI reflection paper published in 2024.

‘The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our reading role in the global innovation race, while ensuring the highest level of patient safety,’ said European Commission for Health and Animal Welfare, Olivér Várhelyi.

The European Commission’s Biotech Act proposal, published in December, notes the promise of AI as a tool to accelerate innovation. New pharmaceutical legislation, meanwhile, aims to accommodate the broader use of AI in regulatory decision-making, and creates additional possibilities for testing AI-driven methods for medicines in a controlled environment.

To realise these benefits, say regulators, AI needs to be expertly managed, including the mitigation of risks. Ethics should be at the forefront of policymaking and regulations, it noted.

As AI continues to evolve, a principles-based approach will help regulators, pharmaceutical companies and medicines developers harness the potential of these technologies while ensuring patient safety and regulatory compliance.