medicines-medical devices-regulatory affairs
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…
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…
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…
Last updated: 17 March 2025 To view updates, click the ‘+’ sign below See updates at the end of this post. Following an announcement in May 2023, the pilot phase of the Innovative Devices Access Pathway (IDAP) was launched on…
The UK MHRA has developed a process to share operational information with health system partners across the UK. This applies to medicines applications submitted via National and International Recognition regulatory routes. For the purposes of operational information sharing, what is…
The table below details the Timeline of proposed changes to the regulatory framework for clinical trials in the UK. Date(s) Event Notes 17 Jan -14 Mar 2022 MHRA public consultation on proposals for legislative changes for clinical trials. This consultation…