A major EU legal milestone was achieved as 2023 drew to a close: the Council of the EU and European Parliament finally reached a provisional agreement on the Artificial Intelligence Act, almost three years after the historic legislation was first proposed by the European Commission.
How The EU’s Landmark AI Act Could Impact The Pharma Industry
With the EU’s AI Act set to enter into force early this year, a life sciences lawyer tells the Pink Sheet how pharmaceutical firms could be affected by the landmark legislation in areas such as clinical trial recruitment and drug dose personalization.

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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.