The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were officially signed into law on 10 April 2025, marking a significant development in the UK clinical trials framework (the Medicines for Human Use...more
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more
Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more