The FDA and EMA have jointly released a collaborative framework based on ten principles for good practice in artificial intelligence (AI) in the drug lifecycle.[1][2][3] These principles provide broad guidelines for the use of AI in evidence generation and monitoring across all stages of a drug, from early research and clinical trials to manufacturing and safety monitoring.[1][3] The principles are intended for drug developers, applicants and marketing authorization holders.[1] They will support future AI guidelines in different jurisdictions and strengthen international cooperation between regulators and stakeholders.[1] The initiative follows the FDA-EU bilateral meeting in April 2024 and is in line with EMA's strategy for the safe and responsible use of AI by 2028.[1] The use of AI in the drug lifecycle has grown significantly in recent years and is helping to accelerate the path from innovation to safe and effective drugs.[1] Guidelines are already being developed in the EU based on the EMA's 2024 reflection paper on AI.[1]