MHRA sets out how medicines regulation will adapt to the era of AI
The UK's MHRA has set out in a document how it is reshaping its regulatory processes for medicines in the era of AI. The statement was published on October 14.
Who is affected and how
- pharmaceuticals
- In marketing authorisation submissions, it is worth aligning the documentation of AI use with MHRA expectations.
- health policy
- The UK approach can be used for comparison with EU and US regulators.
Sources
- MHRA lays out its thinking on AI and medicines regulation - pharmaphorumpharmaphorum.com · Oct 14, 2026
- MHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines - GOV.UKgov.uk · Oct 14, 2026
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