Artificial intelligence in medicine regulation
20 August 2021 – The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published on 16 August 2021.
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 AI failures and the wider impact these would have on AI uptake in medicine development and patients’ health. The report identifies key issues linked to the regulation of future therapies using AI and makes specific recommendations for regulators and stakeholders involved in medicine development to foster the uptake of AI.
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