We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of the vaccine outside of the NHS
Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Information and guidance on a range of medical devices for users and patients.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
Data on the real-world efficacy of the COVID-19 vaccines.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The new presentation of Mounjaro gives four doses for once-a-week treatment over a month.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab).