Brexit Poses Challenges for Medical Devices Companies as UK Goes Its Own Way
While it has been nearly two years since the UK withdrew from the European Union, much still remains uncertain about the direction that the Medicines and Healthcare product Regulatory Agency (MHRA) will take with its requirements. Will change happen, and if so when? It’s a bit of a baptism by fire with the regulators only […]
Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: Developers of orphan drug products face some important changes with the approval process in the UK after Brexit. To help companies prepare, the MHRA published new guidance: “How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)”. While most of […]
/ by admin
Is Brexit putting your clinical trial at risk?
FAO: ALL UK-BASED SPONSORS OF EU CLINICAL TRIALS If you are a UK-based sponsor with a clinical trial in the rest of the EU, Brexit could have a profound impact on the legal status of your study. Clinical trials in the EU are governed by the Clinical Trials Directive 2001/20/EC. According to Article 19 of […]