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
Actions that trial sponsors should consider to build resilience into clinical trial design
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.
How to use a cost effectiveness analysis to evaluate your digital health product.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How investigators and sponsors should manage clinical trials during COVID-19
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke
Support for providers and commissioners to make evidence-based appraisals of how the benefits compare with the costs of various approaches to move care closer to home.
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.