MHRA

An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.

The MHRA leads three new government-backed projects using AI-driven approaches to make medicines safer and bring treatments to patients more quickly.

The government has announced it is slashing the red tape that holds back groundbreaking innovations from coming to market.

List of Field Safety Notices from 13 to 17 October 2025.

How the MHRA makes decisions on what is a medicinal product (borderline products).

How the MHRA processes variations to marketing authorisations.

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.

Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.

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.

The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.

Seven emerging AI healthcare technologies have been selected for the second phase of the MHRA’s AI Airlock programme.