medicines-medical devices-regulatory affairs
AI Airlock Background The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot phases, the programme is working towards key project outputs including an improved regulatory…
Last updated: 30 September 2026 To see updates, click on the ‘+’ sign below. The MHRA has published guidance on a Phase 1, 14-day pilot programme for clinical trials. Below is an attempt to present the information in a Q&A…
Last updated: 17 September 2026 To view updates, click on the ‘+’ sign below The MHRA offers a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after 3rd April…
Last updated: 3 September 2026 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 20 August 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Last updated: 5 August 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in an easy to understand…
Last updated: 27 July 2026 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
Last updated: 26 July 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is…
Last updated: 11 May 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
Last updated: 14 April 2026 To view updates, click on the ‘+’ sign below: On 1 April 2026, the MHRA and NICE launched an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines…