EMA – The EMA just issued a Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle

This reflection paper provides considerations on the use of AI/ML in the lifecycle of medicinal products, including medicinal products development, authorisation, and post-authorisation. Given the rapid development in this field, the aim of this reflection paper is to reflect on the principles that are relevant for regulatory evaluation when these emerging technologies are applied to support safe and effective development, manufacturing and use of medicines. More information on the reflectio...