Clinical trials for medicines: apply for authorisation in the UK

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides comprehensive guidance for conducting Clinical Trials of Investigational Medicinal Products (CTIMPs) under the regulatory framework of The Medicines for Human Use (Clinical Trials) Regulations 2004 and the Human Medicines Regulations 2012. This guidance, applicable until April 28, 2026, outlines the mandatory procedures for obtaining Clinical Trial Authorisation (CTA). Sponsors must be established within the UK or an approved jurisdiction and are required to register all trials on public databases to ensure transparency. Applications must be submitted through the Integrated Research Application System (IRAS) for a 'combined review' by both the MHRA and the Research Ethics Committee (REC), which typically results in a single decision within 60 days. Regulatory challenges identified by the agency include high rates of incomplete submissions; over 50% of applications require additional information due to sponsors failing to adhere to guidance or provide sufficient justification for trial designs. Specific requirements are also detailed for In Vitro Diagnostic (IVD) devices, which must generally carry UKCA or CE markings unless a specific exemption or analytical performance study is approved. Required actions for participants include responding to MHRA requests within 14 days and ensuring all electronic documents are not password-protected. High-risk or first-in-human trials may necessitate expert advisory review, while lower-risk Phase 3 and 4 trials may qualify for an expedited 14-day Notification Scheme. Prompt payment of administrative fees is essential to avoid the suspension of trial authorisations.