medicines-medical devices-regulatory affairs
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…
Last updated: 18 March 2023 See updates at the end of this post. 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…
The MHRA has published detailed guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs), under the following headings: Legal background and scope Submission of information Initial appraisal Studies remaining within EU…
Last updated: 5 April 2024 See updates at the end of the post. The Windsor framework was covered in a previous post. On 9 June 2023, the MHRA published a medicines announcement associated with the framework. It sets out a…
The UK MHRA has launched an Innovation Accelerator service. The service will help provide innovators access to MHRA scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more…
The UK government has responded to the medical devices consultation (the original consultation is half way down the page) held between September and November 2021, with new plans to strengthen the regulation of medical devices in the UK. Following the…
Last updated: 28 February 2022 See updates at the end of this post. The UK MHRA has published guidance on the the Innovative Licensing and Access Pathway (ILAP) for medicines. It aims to accelerate the time to market, facilitating patient…