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
MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Information about the MHRA's Graduate Scheme and how to apply.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance on whether or not your product is a medical device.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Approved countries for batch testing and importation of medicines
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.
Some of the different symbols used on medical devices.
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Guidance and advice for community pharmacies in England providing services to people who use drugs and alcohol.
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (…
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
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).