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:
