Dr Nicola Rose: A new antibiotic is positive news – but it will take more to stay ahead of superbugs
Page summary:
The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.
Change made:
First published.
Time updated:
12:00am, 13 October 2025
MHRA strategy blog series
Page summary:
A series of articles from influential external voices about the challenges and opportunities ahead.
Change made:
First published.
Time updated:
9:01am, 16 October 2025
AI Airlock Simulation Workshops
Page summary:
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Change made:
First published.
Time updated:
9:26am, 16 October 2025
AI Airlock Phase 2 Cohort
Page summary:
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Change made:
First published.
Time updated:
9:28am, 16 October 2025
AI Airlock Sandbox Pilot Programme Report
Page summary:
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Change made:
First published.
Time updated:
9:29am, 16 October 2025
AI Airlock: the regulatory sandbox for AIaMD
Page summary:
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Change made:
Updated to add quote from Lord Vallance
Time updated:
4:54pm, 16 October 2025
AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme
Page summary:
Seven emerging AI healthcare technologies have been selected for the second phase of the MHRA’s AI Airlock programme.
Change made:
Addition of quote from Lord Vallance
Time updated:
6:12pm, 16 October 2025
Clinical investigations for medical devices
Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Updated to include link to combined medicine and device trials guidance.
Time updated:
12:34pm, 17 October 2025
Borderline products: how to tell if your product is a medicine
Page summary:
How the MHRA makes decisions on what is a medicinal product (borderline products).
Change made:
Updated ‘Medicines Borderline Advice Form’.
Time updated:
4:04pm, 17 October 2025
