What happened
On 22 September 2026 the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Regulatory Innovation Office (RIO) issued a call for evidence seeking views on how organisations use or plan to use AI for medicines-safety evaluation, including model development, validation, data access, data sharing and regulatory considerations. Responses will inform the 'Beyond ADMET: AI for medicines safety' regulatory sandbox announced June 2026 and future MHRA regulatory work. Deadline: 11:59pm UK time, 22 December 2026.
Why it matters
This is an authoritative regulatory consultation that will shape how AI-driven predictive safety (ADMET) tools are validated and authorised in UK medicines development — a growing AI deployment area with direct regulatory gatekeeping implications for pharma and AI vendors.
Action needed
Relevant organisations should respond to the survey before 22 December 2026 if they use or plan AI-based medicines-safety approaches, and monitor the forthcoming sandbox and guidance.