MHRA Guidance & Safety

MHRA Raids Illegal Weight Loss Medicine Facility

The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.

MHRA Approves Imlunestrant Tosylate for Breast Cancer

The MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a specific type of advanced or metastatic breast cancer. This approval provides a new therapeutic option for patients who have not responded to prior hormonal treatment.

MHRA Alert: Fake Mounjaro (tirzepatide) KwikPens

The MHRA has issued a notice regarding fake Mounjaro (tirzepatide) 15mg KwikPens dispensed by The Private Pharmacy Clinic in Birmingham. Patients with affected pens are advised to stop use immediately and report to the MHRA. The manufacturer reported five faulty pens.

MHRA Class 2 Medicines Recall: KidNaps Melatonin Oral Solution

The MHRA has issued a Class 2 medicines recall for all batches of KidNaps Melatonin 1mg in 1ml Oral Solution due to out-of-specification stability results. Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are conducting the recall at the wholesaler and pharmacy level.

MHRA Licenses Brensocatib for Non-Cystic Fibrosis Bronchiectasis

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri), the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. This marks a significant advancement in treatment options for NCFB patients in the UK.

MHRA Statement on PATHWAYS Puberty Blocker Trial Safety

The MHRA has issued a statement regarding the PATHWAYS puberty blocker trial, expressing concerns about participant wellbeing and initiating scientific dialogue with the trial sponsor, King's College London. The agency is applying high scrutiny to ensure the safety of potential child and young person participants.

MHRA Approves Zanidatamab for HER2+ Biliary Tract Cancer

The MHRA has approved zanidatamab (Ziihera) for adult patients with HER2-positive biliary tract cancer that has progressed after previous treatment. This approval provides a new treatment option for a specific patient population with an unmet clinical need.

MHRA: UK Medical Device Testing Hits Record High, Backs AI

The UK's MHRA reported a 17% increase in approved medical device clinical investigations in 2025. The agency is implementing measures to support innovation, including a fee waiver pilot for small firms and enhanced support for AI and neurotechnology.

MHRA Medical Device Safety Notices

The MHRA has issued a list of eight medical device safety notices published between February 9-13, 2026. These notices cover various devices including ventilator circuits, tissue reconstructive material, and PET/CT scanners. The MHRA publishes these for informational purposes.

MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks feedback on extending current transitional arrangements and introducing an international reliance route to ensure continued supply and patient access to medical technologies. The deadline for feedback is April 10, 2026.