AI Complexity Not A ‘Free Pass’ To Dodge Regulatory Standards, EMA Warns

Companies that use AI technologies will be responsible for demonstrating that regulatory standards are met and that the data they provide “has not been synthetically generated or completely made up,” an EU workshop heard this week.

EMA
• Source: Shutterstock: Alessandro Zappalorto

Artificial intelligence has many clinical and non-clinical use cases within the drug development lifecycle, but mitigating risks will require a culture where individuals “are not afraid to say that they are wrong,” says a senior EU regulator.

The European Medicines Agency is currently mulling how best to regulate the use of artificial intelligence in the medicines development lifecycle, and this week invited hundreds of pharma industry stakeholders to participate in a two-day workshop on the subject, held jointly with the EU Heads of Medicines Agencies (HMA)

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