Clinical trials have the potential to reshape healthcare and improve lives globally. However, to realise this fully, trials must be well-designed, ethically conducted, and efficiently managed. They need to answer key scientific questions that provide direct benefits to the people they aim to help.
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.
The UK’s National Institute for Health and Care Excellence (NICE) has opened a public consultation on the first updates to its health technology evaluations manual, which was published in January 2022.
The leaders of the European Federation of Pharmaceutical Industries and Associations (EFPIA) have warned that the proposed reforms to the European Commission’s (EC) Pharmaceutical Legislation should be revised as they believe they risk damaging Europe’s capacity for innovation and international competitiveness.
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).
