The EMA and FDA have published a set of 10 'common principles' that should be taken into account when using AI in the development of medicines.
The list has emerged as the adoption of AI among biopharma companies is rapidly accelerating, upending usual practices across the product life cycle from drug discovery through to clinical testing and commercial rollout.
According to the two regulators, the list will underpin future guidance on AI in the US and EU and support international standard-setting.
It gives "broad guidance on AI use in evidence generation and monitoring across all phases of a medicine, from early research and clinical trials to manufacturing and safety monitoring."
Top of the list is that AIs must be human-centric by design and align with ethical values.
They must be developed using a risk-based approach that takes into account the context of their use, and adhere to current legal, ethical, technical, scientific, cybersecurity, and regulatory standards.
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