medicines-medical devices-regulatory affairs
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…
On 17 November 2023, the UK MHRA published updated guidance on change of ownership of Medicines Marketing authorisation, to reflect a new process and application form. This post is an attempt to provide the updated guidance information in a more…
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…
The UK MHRA has announced today that new regulatory recognition routes for medicines will be established using approvals from the following countries: This means that patients will have access to safe and effective medicines that have been approved by trusted…
Last updated:16 August 2023 See updates at the end of the post. The UK MHRA will introduce a series of new measures with support from partners to make it faster and easier to gain approval and to run clinical trials…