MHRA announces streamlined clinical trial review process

Regulatory NewsRegulatory News | 16 July 2021 |  By 

In the wake of the systemic changes flowing from the UK’s exit from the EU, the country’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline review of clinical trials for medicinal products.
Beginning in January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will receive a combined review from MHRA and the UK Research Ethics Services, with collaboration from the UK’s Health Research Authority (HRA). The process is meant to “facilitate rapid startup” of clinical trials so that patients can see earlier benefit from innovative therapies.
The streamlined process will have applicants submitting a single application, which will go before the research ethics committee and be reviewed for authorization of the clinical trial. The ethics sign-off and the clinical trial authorization are issued in one notification. Sponsors who have used the unified application are reporting a reduction of up to 30% in the time required to launch trials, reported MHRA in a 15 July press release announcing the slimmed-down application process.
“This work is part of the transformation of the Integrated Research Application System (IRAS). We are collaborating with the HRA, the devolved administrations, the National Institute for Health Research (NIHR) and other research partners to create a world-class hub for health and social care research in the UK,” wrote MHRA in its announcement. Goals of the overall process include “smooth and intuitive access to research approval, study management, best practice guidance and lay-friendly information about the results of research.”
The combined review process is available to sponsors now, and MHRA encourages applicants to begin using the new pathway in advance of the January 2022 date when it will become the sole means for clinical trial initiation in the UK.
In addition to reducing the paperwork and notification burden for initiating clinical trials, the combined review process may also be used when changes are requested or a clarification is needed. Through a “single unified request,” sponsors will receive a response both from MHRA and the research ethics committee. Similarly, any “subsequent substantial amendments” will also go through the streamlined application and review process.
MHRA’s landing page for CTIMP combined reviews outlines steps sponsors and contract research organizations should take, including giving step-by-step instructions for how to use the IRAS for the combined review and providing links to use when registering for a new account and emailing for assistance.
The combined review process fits into UK’s broader implementation plan for UK clinical research post-Brexit, according to the MHRA announcement, which also cites the importance of lessons in agility and collaboration learned during the global public health emergency of the COVID-19 pandemic. “As we look forward, there is an opportunity to build on what we have learned and achieved and realise a bold and ambitious vision of clinical research delivery,” wrote the regulator.

MHRA announcement


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