medicines-medical devices-regulatory affairs
The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway to publish regulatory and health technology assessment decisions simultaneously. What is the publishing of regulatory and health technology assessment decisions simultaneously expected to…
Last updated: 11 October 2025 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: 4 October 2025 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…
This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…
Last updated: 14 August 2025 To view updates, click on the ‘+’ sign below. On 17 November 2023, the UK MHRA published updated guidance on change of ownership of Medicines Marketing authorisation, to reflect a new process and application form.…
Last updated: 5 August 2025 To see updates, click on the ‘+’ sign below The Windsor framework was covered in a previous post. The guidances in the table below are covered in this post. Only a snapshot of each guidance…
Last updated: 15 September 2025 To view updates, click on the ‘+’ sign below. What is Decentralised Manufacturing? Point of Care (POC) and Modular Manufacture (MM) are collectively described as Decentralised Manufacture (DM). Which product types are included as POC…
Last updated: 15 July 2025 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: 20 June 2025 To view updates, click o the ‘+’ sign below. The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023. About the Innovative Devices Access Pathway (IDAP) The aim of IDAP is to enable and…
Last updated: 22 May 2025 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…