Since leaving the EU, the United Kingdom has run its own health regulatory regime. The Medicines and Healthcare products Regulatory Agency licenses medicines and regulates medical devices, including the UKCA marking and the future UK medical devices framework. NICE appraises the clinical and cost effectiveness of health technologies for the NHS. This page collects the UK regulatory updates HealthSignal tracks across medicines, devices, digital health, and health technology assessment, from official public sources only.
People in England with a type of chronic heart failure could benefit from a new treatment option. Our final draft guidance recommends finerenone for adults with chronic heart failure with preserved or mildly reduced e...
UK NICEThe MHRA is strengthening safety warnings for all botulinum toxin type A products, following reports of rare cases of botulism linked to their use.
UK MHRAMedicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority plasma-derived medicinal products.
UK MHRAGuidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRACases of iatrogenic botulism have been reported following the therapeutic or cosmetic use of botulinum toxin containing products where the toxin’s effect extends beyond the area of treatment. Patients should seek imme...
UK MHRAHow to use the procedure for medicines licensing applications.
UK MHRAList of Field Safety Notices from 6 to 10 July 2026.
UK MHRAAdvice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
UK MHRABecton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
UK MHRAA procedure that keeps donor livers supplied with oxygen inside the body before removal has been recommended for NHS use and could help more people on the transplant waiting list.
UK NICEThe semaglutide injection has been approved to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis.
UK MHRAThis guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.
UK MHRAGuidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.
UK MHRAMHRA CEO argues that for the UK’s long-term health and prosperity, regulation should help lead, rather than follow, innovation
UK MHRAA regulator’s view on what the new UK Health Data Research Service must deliver.
UK MHRAThis guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.
UK MHRAThis guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
UK MHRAPeople with polyendocrine metabolic ovarian syndrome (PMOS) should have their condition diagnosed sooner and be offered an annual review to monitor symptoms, treatment and long-term health risks, according to our draf...
UK NICEList of Field Safety Notices from 22 to 26 June 2026.
UK MHRARelonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
UK MHRAHow the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
UK MHRAProvide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRAThe Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRABrancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
UK MHRAWe can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
UK MHRAThis register contains all websites that are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell medicines online, in Northern Ireland.
UK MHRAA new treatment option is now available on the NHS for cervical cancer that has come back or spread to other parts of the body, following our final draft guidance published today.
UK NICEList of Field Safety Notices from 15 to 19 June 2026.
UK MHRAThe MHRA, Advertising Standards Authority, and the General Pharmaceutical Council have issued a warning to businesses seeking to promote newly authorised medicines, as well as those that do not yet have a marketing au...
UK MHRAOrbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing ...
UK MHRAHealthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykin...
UK Drug Safety UpdateLearn how NICE's healthtech guidance is accelerating NHS adoption of a simple bowel cancer test, preventing 140,000 unnecessary urgent referrals a year while keeping cancer detection rates stable.
UK NICEAs with any medicine, the MHRA will keep the safety and effectiveness of the adrenaline nasal spray under close review.
UK MHRAHaving met the MHRA’s rigorous standards of safety, quality and effectiveness, the semaglutide tablet has been approved in the UK for weight loss and weight management.
UK MHRAFindings from the National Commission into the Regulation of AI in Healthcare's call for evidence and wider research and engagement activities.
UK MHRAProposed changes to the headline payment percentage and consultation procedure of the statutory scheme to control the cost of branded health service medicines.
UK DHSCAs with all medicines, the MHRA will keep the safety and effectiveness of Nipolcalimab under close review.
UK MHRAThe MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
UK MHRAThe adjuvanted trivalent influenza vaccine works by stimulating the immune system to produce its own protection against flu.
UK MHRATeva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed fo...
UK MHRAWomen with type 1 diabetes who are pregnant or planning a pregnancy should be offered a pregnancy-specific 'artificial pancreas' device. That is the recommendation in draft guidance published today by NICE.
UK NICEBecton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
UK MHRAAs with any medicine, the MHRA will keep the safety and effectiveness of rilzabrutinib under close review.
UK MHRAPatients taking Crescent Pharma Limited Ramipril 2.5mg capsules are advised to check their packaging for batch number GR155023 and contact their pharmacy if any blister strips inside are labelled as Ramipril 10mg.
UK MHRACrescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
UK MHRAMHRA are seeking feedback on a proposed framework for rare disease therapies.
UK MHRA