Regulatory  ·  2026-09-28

MHRA and Regulatory Innovation Office open 'Beyond ADMET: AI for medicines safety' call for evidence

RegulatoryMedium impactUnited Kingdom
On 22 September 2026 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the Regulatory Innovation Office (RIO) launched a call for evidence (survey) on the use of AI in medicines safety — predicting/assessing ADMET (absorption, distribution, metabolism, excretion, toxicity) by integrating traditional preclinical data with clinical and real-world data. Findings will inform the June-2026-announced 'Beyond ADMET: AI for medicines safety' regulatory sandbox and future regulatory work. Responses due 22 December 2026.
This is a binding-process consultation feeding an MHRA regulatory sandbox for AI in drug-safety evaluation — directly relevant to AI deployers/developers in life sciences, toxicology and preclinical/clinical research, and to the broader shift toward AI-enabled regulatory assessment of medicines in the UK.
Organisations using or planning AI for medicines safety (across tox, preclinical, clinical, biotech and AI sectors) should submit the MHRA questionnaire by 11:59pm UK time, 22 December 2026, to shape the sandbox and future guidance.
GOV.UK — Beyond ADMET: AI for medicines safety - survey
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