Lexology September 6, 2023
Sidley Austin LLP

Globally, the rapid advancement of artificial intelligence (AI) and machine learning (ML) raises fundamental questions about how the technology can be used. Drug approval authorities are now also taking part in this discussion, resulting in emerging and evolving guidelines and principles for drug companies.

This Sidley Update looks at the emerging views of the EU, U.S., and the UK drug approval authorities.

EU – European Medicines Agency (EMA) AI Paper: Reflection Paper on the Use of AI in the Medicinal Product Lifecycle

In June 2023, the EMA published a draft reflection paper (AI Paper) setting out how the EMA expects both marketing authorization (MA) applicants and holders to use AI and ML. The AI Paper is open for public comments...

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Topics: AI (Artificial Intelligence), Biotechnology, Govt Agencies, Pharma, Pharma / Biotech, Regulations, Technology
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