EMA and FDA set common principles for AI in medicine development
Advancing safe, ethical and aligned AI practices across the medicines lifecycle
NewsHumanData on medicines
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.
The principles give broad guidance on AI use in evidence generation and monitoring across all phases of a medicine, from early research and clinical trials to manufacturing and safety monitoring.
The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders. They will underpin future AI guidance in the different jurisdictions and support enhanced international collaboration among regulators, organisations setting technical standards and other stakeholders. Guideline development in the European Union (EU) is already underway, building on the EMA AI reflection paper published in 2024.
"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 use of AI technologies across the medicines lifecycle has increased significantly in recent years. As emphasised in the European Commission’s Biotech Act proposal, AI holds great promise as a tool to accelerate the path from innovation to safe and effective medicines. The new pharmaceutical legislation accommodates the broader use of AI in the lifecycle of medicines in regulatory decision-making, and creates additional possibilities for testing innovative AI driven methods for medicines in a controlled environment.
To realise these benefits, AI needs to be expertly managed, including the mitigation of risks. 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 and animal safety and regulatory compliance. Over time, these principles will be supplemented by additional EU guidance taking into account the applicable legal requirements and relevant new EU legislation in the area of medicines.
This EMA-FDA 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 with its goal of leveraging data, digitalisation and AI, and in the joint Heads of Medicines Agencies and EMA multiannual Data and AI workplan.
With ethics at the forefront, the Agency will continue to explore opportunities for global convergence on AI topics to facilitate responsible innovation globally, in close collaboration with international public health partners.