16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the challenges that the use of artificial intelligence poses for global medicines regulation, in a report published today.

AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are increasingly being applied across all stages of a medicine’s lifecycle: from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimisation. 

This range of applications brings with it regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of artificial intelligence failures and the wider impact these would have on artificial intelligence uptake in medicine development and patients’ health.

Read EMA press release