medicines-medical devices-regulatory affairs
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…
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…
The UK MHRA is consulting on the future regulation of medical devices in the UK. Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in…
The UK MHRA is seeking views on innovative medicines manufacture at point of care. It has launched a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing. What is POC manufacturing? POC manufacturing refers to the manufacture…
Last updated 25 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA has launched the Early Access to Medicines Scheme (EAMS) consultation. What is the EAMS scheme? How does the scheme work? EAMS is essentially…
This post is an attempt to provide the requirements for conducting clinical trials in the UK post Brexit i.e. since 1 January 2021. The information provided is by no means exhaustive.. Please refer to the resources at the end of…
The UK MHRA has issued new guidance on authorisations and procedures required to Import Investigational Medicinal Products (IMPs) from countries on a list, to Great Britain (GB). Information is also provided on the importation of authorised/unathorised: non-investigational medicinal products unmodified…