MHRA Safety Roundup: July 2025
Summary of the latest safety advice for medicines and medical device users
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Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
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Standard: Statement of Policy Intent: Early Access to Innovative Medical Devices
The MHRA’s initial plans on an Early Access service, which will be developed further throughout 2025.
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MHRA outlines intent to speed up patient access to innovative medical devices
Statement of Policy Intent sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
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Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
The approval is supported by a study involving 453 adults with advanced platinum-resistant cancers of the ovary, fallopian tubes and the peritoneum that were FRα positive
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Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004)
The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken.
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Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens.
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Tofersen approved by the MHRA to treat rare inherited form of motor neurone disease
New genetic therapy approved for SOD1-ALS brings targeted treatment option to patients in the UK
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Consultation on the International Council for Harmonisation Guideline E20 for adaptive clinical trial design
The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.
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Summer ready: MHRA issues updated guidance on medicines and medical devices during holiday season
As the UK enters the heart of summer – with temperatures rising and families holidaying – the Medicines and Healthcare products Regulatory Agency (MHRA) is reinforcing essential safety advice for anyone using medicines or medical devices.
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Form: Decentralised Manufacture: The designation step application form
Application Form to be completed by an Applicant and sent to the MHRA requesting consideration of an award of a Decentralised Manufacture (DM) Designation.
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Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.