medicines-medical devices-regulatory affairs
Last updated: 9 May 2025 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: 13 May 2025 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: 4 April 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on MAAs based upon a rolling review, in a Q&A format. Always read the guidance on this…
Last updated: 3 April 2025 To view updates, click the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this procedure…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the Unfettered Access Procedure (UAP) for marketing authorisations approved in Northern Ireland in a Q&A format.…
Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales…
The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations. This webinar details the upcoming implementation of new clinical trial regulations in the UK. How you might use…
Last updated: 9 April 2025 To view updates, click on the ‘+’ sign below: The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The…
Last updated 25 October 2024 To view updates, click on the ‘+’ sign below The MHRA has published guidance on how to submit medicines pipeline information. It is requesting current or potential medicines Marketing Authorisation Holders (MAH) to provide information…