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Proposed updates to the regulation of medical devices
While it might be challenging for manufacturers of medical devices to navigate the evolving regulations of medical devices in Great Britain following Brexit, the MHRA recently published updates, which offer some clarity in terms of timing. However, it is all still subject to parliamentary approval. CE marks In October 2022, the MHRA published an update, stating that the government intends to introduce legislation that extends the acceptance of medical devices with valid CE marks on the Great Britain...
May 10, 2023
3 min read
What the replication crisis means for AI and drug ...
Back in May 2016, the scientific publication Nature surveyed...
May 4, 2023
2 min read
Single-arm clinical trials: EMA launches consultat...
In contrast to randomised controlled trials (RCTs), single-arm...
April 26, 2023
2 min read
The Windsor Framework: One Step Closer to a Single UK market
Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this...
April 3, 2023
5 min read
UK Clinical Trials Changes – a Leg Up or a Step Down?
The government recently consulted on proposals intended to improve the UK’s clinical trials legislation...
April 3, 2023
2 min read
The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector
The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased...
February 17, 2023
9 min read
Guide to EU and UK Pharmaceutical Regulatory Law 2023
Eighth Edition, Edited by Sally Shorthose The Guide to EU and UK Pharmaceutical Regulatory...
January 31, 2023
3 min read
Publication of CNIL standards on health data processing implemented in the context of early access and compassionate use authorisations
The French data protection authority (Commission Nationale de l'Informatique et des Libertés...
January 16, 2023
2 min read
Rebranding generics as branded medicines – CJEU issues new guidance
The CJEU has provided welcome new guidance on when parallel importers can rebrand generic medicines with...
December 9, 2022
5 min read
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