Some cookies are essential to the running of the website, while others (analytics) help us to make improvements. We also incorporate functionality from other websites, such as video, social media feeds and ReachDeck (text-to-speech and translations services) which may set cookies. More on how we use cookies
This website uses text-to-speech software called ReachDeck to read and / or translate its content. To use ReachDeck, you must allow ReachDeck cookies; the ReachDeck icon will then appear at the bottom right of your screen.
You can find out more about how ReachDeck uses cookies or change your cookie preferences at any time by going to our cookies page.
Allow ReachDeck cookies Do not use ReachDeck
Please find service updates and current visiting rules in our COVID-19 section.
This site is best viewed with a modern browser. You appear to be using an old version of Internet Explorer.
All studies falling into the category of Clinical Trials will require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA).
The EU Clinical Trials Directive (EUCTD) is a legal document which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted.
It was implemented into UK law in May 2004, as the Medicines for Human Use (Clinical Trials) Regulations 2004, and has since been amended (2006a, 2006b, 2008).
For details on making submissions to MHRA, and the fees, please visit: