6 November 2025
From the newsfeeds of the Medicines and Healthcare products Regulation Agency, Arex Advisor has rounded up a selection of highlights from October 2025.
UK cuts clinical-trial approval timelines with AI and reforms
7 October 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has reduced average approval times for clinical trials in the UK from roughly 91 days to 41 days, following major reforms including use of AI and risk-proportionate review pathways. Read more
Innovative Licensing Pathway supports early collaboration with UK health bodies
15 October 2025
Through the UK’s Innovative Licensing and Access Pathway (ILAP), developers collaborate with the NHS, the Medicines and Healthcare products Regulatory Agency (MHRA), and health technology assessment bodies from the early stages of clinical development. The pathway is designed to accelerate patient access to innovative medicines by fostering early and coordinated regulatory and clinical input. Read more
MHRA updates guidance on processing variations to marketing authorisations
16 October 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on how it processes variations to marketing authorisations (MAs). The document outlines procedures for submitting, assessing, and implementing changes to authorised medicines in the UK, helping marketing authorisation holders ensure ongoing compliance with national requirements. Read more
MHRA signals major overhaul for rare disease treatment framework
2 November 2025
The MHRA has published a position paper setting out its intention to overhaul its regulatory framework for rare-disease therapies in the UK. Read more
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