medicines-medical devices-regulatory affairs
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: 28 October 2024 Click on the + sign below to see the updates to this post. On 27 February 2023, the European Commission and the Government of the United Kingdom announced a political agreement in principal on a…
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 30 April 2024, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government. On 9 May 2024,…
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…
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…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…