The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
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Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
MHRA Safety Roundup: October 2025
Summary of the latest safety advice for medicines and medical device users
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
Class 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann’s Solution for infusion) in Viaflo 1000ml, EL(25)A/46
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Corporate report: Human Medicines Regulations 2012 Advisory Bodies Annual Report 2024
Annual Report of the Human Medicines Regulations 2012 Advisory Bodies – the Commission on Human Medicines (CHM) and the British Pharmacopoeia Commission.