medicines-medical devices-regulatory affairs
Last updated: 25 March 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…
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…
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…
Last updated: 23 September 2024 To see updates, click on the ‘+’ sign below. On 9 May, the MHRA launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). On 30 April, the MHRA set out its…
The MHRA: The proposed framework is still in draft, and the final version would be integral with the future core regulations. With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will…
The following updates have been added to this guidance: Further information is available at the link below. Source: MHRA
Last updated: 26 March 2025 To see updates, click the’+’ sign below: This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation in…