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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 review of the benefits and risks.
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 condition that runs in families caused by a protein called transthyretin…
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 without delay.
…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 ensuring delivery for all who need its services – patients and the…
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 adults and adolescents aged 12-years-old and older who weigh…
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 other treatments have not worked.
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 harm to children if valproate is used by a father at conception.…
Following a thorough review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establish a causal relationship between Glucagon-Like Peptide-1 (GLP-1) receptor agonists and suicidal behaviour, suicidal ideation, self-injury…
As the new school year looms, the MHRA sets out key advice on children's medicines and medical devices.
The MHRA has approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant.
…Dr Junaid Bajwa, Professor Graham Cooke, Dr Paul Goldsmith and Rajakumari Long have had their appointments as Non-Executive Directors (NEDs) of the Medicines and Healthcare products Regulatory Agency extended from 1 September 2024 until 31 August 2025.…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 22 August 2024, approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer which has one or more abnormal…
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