The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance "Clinical Trials for Medicines – Applying for Authorisation in the UK". This guidance details how to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make changes to your application.
A Clinical Trial Authorisation (CTA) is required for any clinical trial involving investigational medicinal products (IMPs) in the UK.
This includes trials testing new drugs, biologics, or significant modifications to existing products. The guidance outlines the specific scenarios where a CTA is necessary and the process for determining whether your study qualifies.
Two or more persons or organisations can also sponsor clinical trials. This is referred to as joint or co-sponsorship. A sponsor of a clinical trial needs to be established in the UK or a country on an approved country list which would initially include EU/European Economic Area (EEA) countries. If the sponsor is not based in the UK, a legal representative must be appointed within the UK to ensure compliance with UK regulations.
All clinical trials must be registered in a publicly accessible database before recruitment begins. Registration ensures transparency and allows for public scrutiny of the research. The MHRA offers a combined review service for clinical trials involving Investigational Medicinal Products (IMPs). This service allows sponsors to submit a single application for the CTA and the ethical review, streamlining the approval process.
The guidance lists all required documents and offers advice on how to prepare and submit them correctly. The initial combined review assessment will be completed within 30 days of being submitted. Within 60 days of receiving the original valid application, MHRA will inform the applicant of the decision. If an extension has been agreed to the response date, the timeline for the final decision may be impacted.
The guidance provides on how to submit these trials for review, including the need for expert advice and additional documentation and a detailed breakdown of the applicable fees and the payment process. It also explains when and how to seek this advice and what additional information may be needed.
This summary provides an overview of the key aspects of applying for clinical trial authorisation in the UK as outlined by the MHRA. For more detailed information, refer to the full guidance on the MHRA website.
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