AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
Page summary:
MHRA opens second round of applications to test cutting-edge AI medical technologies following successful pilot phase.
Change made:
First published.
Time updated:
9:31am, 23 June 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:
Webpage has been simplified, added the background context into a separate pageAdded new phase 2 detail to main page and a new page for the application form
Time updated:
10:00am, 23 June 2025
AI Airlock Phase 2 application
Page summary:
The call for application for phase 2 of the AI Airlock is now open. This page contains information on eligibility and how to apply
Change made:
First published.
Time updated:
10:00am, 23 June 2025
AI Airlock Background
Page summary:
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
Change made:
First published.
Time updated:
10:20am, 23 June 2025
UK MHRA leads safe use of AI in healthcare as first country in new global network
Page summary:
The MHRA will help shape international rules for AI in healthcare – speeding up access to safe, effective technologies into the NHS and worldwide.
Change made:
First published.
Time updated:
2:20pm, 24 June 2025
MHRA Safety Roundup: June 2025
Page summary:
Summary of the latest safety advice for medicines and medical device users
Change made:
First published.
Time updated:
3:42pm, 24 June 2025
If you have any questions about the medical content in this email, contact MHRA on info@mhra.gov.uk
Clinical trials for medicines: apply for approval in the UK
Page summary:
How to apply for a clinical trial from 28 April 2026, including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change made:
First published.
Time updated:
10:07am, 25 June 2025
Clinical trials for medicines: expert advice
Page summary:
Clinical trial applications that need expert advice from a specialist group or committee.
Change made:
First published.
Time updated:
10:07am, 25 June 2025
Clinical trials regulations: transitional arrangements
Page summary:
Guidance on transitional arrangements for applying for clinical trial approval.
Change made:
First published.
Time updated:
10:07am, 25 June 2025
MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2025 to 2026
Page summary:
These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years.
Change made:
Business plan 2025 to 2026 published.
Time updated:
11:00am, 25 June 2025
MHRA publishes final Business Plan for 2023-2026 Corporate Plan
Page summary:
The new Business Plan sets out priorities for 2025–26: Protecting public safety and maintaining public trust; delivering efficient, predictable services through regulatory excellence; being an agile organisation that drives innovation; being a great place to work and providing excellent customer service.
Change made:
First published.
Time updated:
11:10am, 25 June 2025
MHRA seizes 7.7 million doses of illegal medicines and removes hundreds of illegal online listings as part of Operation Pangea
Page summary:
Operation Pangea brings together health regulators, customs authorities, law enforcement agencies, and private sector partners to tackle the threat posed by global criminal networks
Change made:
First published.
Time updated:
5:14pm, 25 June 2025
AI Airlock, CERSIs and a new global AI network for health regulators
Page summary:
Med Tech Regs blog, June 2025: A focus on Software and AI.
Change made:
First published.
Time updated:
9:32am, 27 June 2025
