From 1 January 2025, the Windsor Framework will simplify medicine licensing across the UK. The MHRA will issue UK-wide licenses, replacing separate ones for Great Britain and Northern Ireland. Medicines will have the same packaging across the country.
The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting feedback on plans to end use of the European Commission Decision Reliance Procedure (ECDRP) to bring medicines to market.
The UK’s Department for Business and Trade (DBT) has announced an indefinite extension to the use of CE marking for businesses in the UK, beyond the 2024 deadline. The aim is to cut business costs and products’ time to market. The government intends to implement major reforms to the current regulatory framework for medical devices, with core parts set to apply from 1 July 2025.
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) annual report and accounts for 2022-2023 was printed on 19 July 2023. The report outlines achievements during the year, such as its evolution into a ‘One Agency’ organisation, uniting its regulatory, research and standards and clinical data service.
New biotechs and small pharma companies find it hard to take their products from discovery to market because of a lack of capital and early-stage expertise. Dr Malcolm Barratt-Johnson, PharmaMedic Consultancy’s Managing Director, says the traditional routes do not work and offers a plan to help innovators move their products forward.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published its corporate plan for the next three years, featuring a focus on patient access to innovation.
Four important themes for the life sciences were the focus of the Professional Industry Network Group (PING) conference, held in June 2023. These included the position of the Medicines and Healthcare products Regulatory Agency (MHRA) post the COVID-19 pandemic, the implications of the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) and the proposed Voluntary Scheme for Pricing, Access and Growth (VPAG), plus whether there were adequate staffing and premises to support the sector.
The much anticipated O’Shaughnessy report examining commercial clinical trials in the UK was published at the end of May 2023. Its findings have prompted the UK government to initiate a series of actions, in response to its 27 recommendations, that are designed to make the UK a world leader in this important part of the life sciences industry.
The government has announced that new measures laid out in the Windsor Framework regarding the supply of medicines to Northern Ireland will commence from 1 January 2025. This extends the previous deadline for compliance, which was 31 December 2023.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting public feedback on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
