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UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis

 
• By Eliza Slawther

The MHRA’s regulatory strategy on AI outlines key areas where this technology could be used to improve the agency’s own processes, and says that the use of AI to develop drugs will not change the questions it asks companies.

The UK’s drug regulator, the MHRA, released its strategic approach to regulating AI in medicinal products on 30 April. Much of the guidance focuses on how the MHRA plans to use AI during the regulatory assessment process for drugs, and on AI as a medical device.

The organization also said that machine learning and AI could be used to enhance its understanding of real-world data (RWD), although at this stage there were “significant uncertainties” around the...

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