Pharma Industry Weighs In On EMA’s AI Regulation Proposals

Consistency and coherence with other relevant regulations should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence in the drug lifecycle, pharmaceutical industry representatives have said.

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Pharma and medtech representatives gave their feedback on the European Medicines Agency’s proposed regulatory strategy for AI during a hybrid workshop this week, which saw hundreds of industry stakeholders assemble in-person and online.

Stephen Pyke, chief clinical data and digital officer for real-world evidence and AI innovation at the CRO Parexel, said during the meeting that agencies should be “aware of inconsistencies in the approach or undesirable restrictions,

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