Medical Devices Back in the Spotlight

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: Preparation for the new regulations  The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will […]

Data protection to take centre stage in 2021

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]

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 […]