8 April 2026
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from the past month.
MHRA clarifies GMP requirements for radiopharmaceuticals in clinical trials
9 March 2026
The MHRA has issued guidance on Good Manufacturing Practice for radiopharmaceutical investigational medicinal products used in clinical trials. The document outlines quality and handling requirements specific to these products, helping sponsors ensure compliance while supporting safe and effective trial conduct. Read more
MHRA and NICE launch joint pathway to speed patient access to medicines
17 March 2026
The MHRA and the National Institute for Health and Care Excellence (NICE) have introduced a streamlined approval process expected to give patients in England access to some new medicines up to six months earlier. The aligned pathway and enhanced advice service aim to improve coordination between regulatory and HTA decisions, offering greater predictability for companies and faster access for patients. Read more
MHRA clarifies application of ICH E6(R3) GCP in UK trials
27 March 2026
The Medicines and Healthcare products Regulatory Agency has published guidance on how the updated ICH E6(R3) Good Clinical Practice principles are implemented and enforced within UK clinical trial legislation. The document helps sponsors and investigators understand compliance expectations, supporting high-quality, ethical clinical research in the UK. Read more
MHRA outlines risk-based approach to clinical trial quality
27 March 2026
The MHRA has issued guidance on applying quality-by-design principles, risk-based quality management, and proportionate oversight in clinical trials. The approach aims to help sponsors design more efficient studies while maintaining participant safety and data integrity through targeted, risk-based controls. Read more
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