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
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2025.
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.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
How we engage and involve patients and the public in our regulatory decision-making.
Guidance for medical device manufacturers on when to use electronic instructions and how to comply with the regulations.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to m…
Information relating to the disapplication of falsified medicines under UK Law.
For manufacturers reporting adverse incidents with intraocular lenses under the vigilance system.
Information on how to request assistance from the NSDR.
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
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 and requires JavaScript).