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
The full government response to the Lord O'Shaughnessy independent review of UK commercial clinical trials.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
How to use a before-and-after study to evaluate your digital health product.
How to use a case-control study to evaluate your digital health product.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to use a factorial randomised controlled trial to evaluate your digital health product.
The MHRA has today launched a public consultation on the revised ICH guideline on Good Clinical Practice.
Information about the EU Regulations and their implementation in Northern Ireland
How to join the phase I accreditation scheme.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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.