Applying for Authorisation – UK Example

Executive Summary

Clinical trials are an integral source of data for many new medicines, and form the basis of submissions for both regulatory (efficacy and safety) and pricing and reimbursement stages of market access. The process for setting up a clinical trial is different across Europe; we have explained the UK system on this page. The MHRA administers clinical trials in the UK. Read this page to understand the role it plays and the obligations on the company when initiating a trial.