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
Register to vote Register by 18 June to vote in the General Election on 4 July.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to use an ethnographic study to evaluate your digital health product.
Actions that trial sponsors should consider to build resilience into clinical trial design
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
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.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
How investigators and sponsors should manage clinical trials during COVID-19
Helping public health practitioners conducting evaluations – using process evaluations to explain how complex interventions work.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to use a clinical audit to evaluate your digital health product.
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).