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Catégorie : ELSIBI

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Access Consortium Promise Pilot Pathway

The Access Consortium working group for new active substances has established an aligned process for priority review, which includes the decision on priority status. In order to facilitate the process for applicants, common timelines for...

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Software and Artificial Intelligence (AI) as a Medical Device

Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device, including Artificial Intelligence as a Medical Device. Read the news from Medicines and Healthcare products Regulatory Agency published...