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The ninth annual #MedSafetyWeek takes place this week, with regulators from 94 countries and 107 organisations taking part across the globe.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 30 October, approved the medicine sugemalimab (Eqjubi) to treat adult patients with a type of lung cancer called ‘non-small cell lung cancer’.
The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding healthcare professionals to ensure patients are aware of the known side effects of glucagon-like peptide-1 (GLP-1) receptor agonists.
Medicines and Healthcare products Regulatory Agency (MHRA) is highlighting our work training multiple World Health Organisation (WHO) polio laboratories around the world.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 October 2024, approved a licence for the medicine donanemab (Kisunla) for use in the early stages of Alzheimer’s disease, following a thorough revi…
The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future reg…
The UK will be the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive …
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elafibranor (Iqirvo) to treat adult patients with a rare type of liver disease known as primary biliary cholangitis (PBC).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 10 October, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the KP.2 COVID-19 subvariant for adults.
The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report any safety problem with their device through the MHRA Yellow Card scheme …
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched its ambitious new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products while en…
Information on the other regulatory bodies responsible for e-cigarette and vape products.
The Medicines and Healthcare products Regulatory Agency (MHRA) has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in…
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC). It is used when othe…
Submission and approval enabled of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies.
New strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices.
Men taking valproate and their partners are being advised by the Medicines and Healthcare products Regulatory Agency (MHRA) to use effective contraception because of new data suggesting a potential small increased risk of ha…
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