medicines-medical devices-regulatory affairs
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…
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 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…
In 2021, the MHRA held a public consultation seeking views on a legislative proposal to introduce a new regulatory framework for the manufacture and supply of Point of Care (POC) products. This post is about the formal government response to that consultation.…
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 Sebruary 2022 See updates at the end of the post. The UK MHRA has recently published the Target Development Profile (TDP) Toolkit to accompany the Innovative Licensing and Access Pathway (ILAP) licensing route available since the beginning…
Last updated: 16 August 2023 See updates at the end of the post. The MHRA has launched a consultation on the UK clinical trials legislation. It is consulting on a set of far-reaching proposals to improve and strengthen the UK…