Artificial Intelligence (AI) systems are gradually becoming a dominant tool supporting intellectual work and powering automation across all walks of life. The European medicines regulatory network’s (EMRN) vision on AI is for a regulatory system harnessing the capabilities of AI for personal productivity, process automation and systems efficiency, increased insights into data and strengthened decision-support for the benefit of public and animal health. The increasingly sophisticated nature and the pace of change of AI bring opportunities but also challenges. The application of AI requires a collaborative, coordinated strategy to maximise the benefits from AI while ensuring that uncertainty is adequately explored, and risks are mitigated.
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