medicines-medical devices-regulatory affairs
Last updated: 14 February 2024 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 19 September 2023. Innovators are invited to submit…
Last updated: 12 January 2024 See updates at the end of the post. The UK MHRA has published guidance on the Project Orbis initiative. Please read this post in conjunction with the MHRA guidance. What is Project Orbis initiative is…
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…
Last updated: 16 June 2023 See updates at the end of the post. The UK MHRA has published guidance on 150-day assessment for national applications for medicines from 1 January 2021. The 150-day assessment for national applications The MHRA offers…
This Guidance on Centrally Authorised Products (CAPs) Bridging Mechanism for Northern Ireland will apply until the Windsor Framework takes effect . When will the Windsor framework come into effect effect? The Windsor Framework will come into effect on 1 January 2025. Which…
The UK will launch a new regulatory Innovative Devices Access Pathway (IDAP) later in 2023. What is the current status of the pathway? Plans are advancing for a new regulatory pathway that facilitates the development of innovative technologies, by providing…
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…