medicines-medical devices-regulatory affairs
Last updated: 21 November 2024 To see updates, click on the ‘+’ sign below. Post Brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland…
Last updated: 20 November 2024 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…
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 November 2024 See updates at the end of this post. The UK MHRA has published guidance on the the Innovative Licensing and Access Pathway (ILAP) for medicines. The pathway brings together innovative approaches to support the safe,…
Last updated: 9 November 2024 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…
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 pathway has seen an unprecedented number of applications and 160+ Innovation Passports have been…
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…
This guidance has been updated. It gives an overview of Orphan medicinal products to support development in rare disease, marketing exclusivity for the products, and how to apply. The authorisation of orphan medicinal products will change following implementation of the…
From 1 January 2025, there are changes to the legislation which affect Reference Medicinal Products (RMPs) used to support abridged applications for UK-wide marketing authorisations. Reference medicinal products (RMPs) are required for new generic medicines and other abridged marketing authorisation…
The MHRA offers a scheme for applications under exceptional circumstances. For what medicines is the MHRA scheme for marketing authorisation under exceptional circumstances available? The MHRA’s scheme for applications under exceptional circumstances is available for medicines where a comprehensive data package cannot…