Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials for Medicines: Apply for Authorisation in the UK" that provides detailed instructions on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The purpose of this guide is to provide information and instructions on the process of applying for authorization to conduct clinical trials in the United Kingdom. It also outlines the regulatory framework and the steps and requirements that need to be completed to obtain authorization.
The recent update was the inclusion of a new section about the New Notification Scheme. As a result of the new Notification Scheme, “initial” clinical trial authorisations (CTAs) can be processed more efficiently and risk-proportionately. At the moment, this scheme does not apply to CTA applications for first-in-human (FIH), Phase 1 or Phase 2, or amendments; it only applies to Phase 4 and certain Phase 3 clinical trials deemed to be less risky.
If the sponsor can demonstrate that the trial meets the inclusion criteria, the MHRA will process CTA applications under this scheme within 14 days instead of the statutory 30 days. All applicants (commercials and non-commercials) whose trials meet these criteria should participate in the scheme by registering their interest.
MHRA acceptance of an application under the new Notification Scheme will be confirmed within 14 calendar days from the application received effective date and authorisation by the MHRA will be granted unless any criterion is not suitably met. The new Notification Scheme is subject to our existing fees.
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