The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly outlined ten guiding principles for good artificial intelligence (AI) practice across the medicines lifecycle. These principles provide broad guidance on using AI in evidence generation, clinical trials, manufacturing, and post-market safety monitoring.
The guidance is intended for medicine developers, marketing authorisation applicants, and holders. It will form the foundation for future AI regulations in both jurisdictions and strengthen international collaboration among regulators, technical standards organisations, and other stakeholders. In the European Union, guideline development is already underway, building on EMA’s AI reflection paper published in 2024.
Strengthening EU-US Collaboration
European Commissioner for Health and Animal Welfare, Olivér Várhelyi, highlighted the significance of the initiative: “The guiding principles of good AI practice in drug development mark a first step in renewed EU-US cooperation on novel medical technologies. They demonstrate how we can collaborate across the Atlantic to lead in global innovation while ensuring the highest levels of patient safety.”
AI’s Growing Role in Medicine
The use of AI technologies in medicine development has accelerated in recent years. As emphasised in the European Commission’s Biotech Act proposal, AI can significantly speed up the journey from innovation to safe and effective medicines. New pharmaceutical legislation supports broader AI adoption in regulatory decision-making and allows controlled testing of innovative AI-driven methods in the development of medicines.
Ensuring Safe and Responsible Use
To realise AI’s potential, risks must be carefully managed. The principles-based approach helps regulators, pharmaceutical companies, and developers harness AI responsibly, ensuring patient and animal safety and regulatory compliance. Over time, the EMA will supplement these principles with additional EU guidance that incorporates applicable legal requirements and emerging legislation.
Building on Ongoing Collaboration
This initiative builds on collaborative work following the FDA-EU Bilateral meeting in April 2024. It aligns with EMA’s mission to promote the safe and responsible use of AI, as outlined in the European Medicines Agencies Network Strategy (EMANS) to 2028, which focuses on leveraging data, digitalisation, and AI. It also complements the joint Heads of Medicines Agencies and EMA multiannual Data and AI workplan. As reported by pharmabiz.co, with ethics at the forefront, EMA will continue exploring opportunities for global alignment on AI, supporting responsible innovation worldwide in close cooperation with international public health partners.