 Welcome to the latest edition of MHRA News, our monthly newsletter for industry where we update you on our most recent activities.
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 The latest MHRA performance data show that clinical trials and investigations applications continue to be handled within statutory timescales. Since September 2023, all clinical trial applications have been assessed within the 30 days, with no backlogs.
Regulatory assessments for clinical trials have been completed in an average of 28 days for initial assessments (within the statutory timescale of 30 days) and an average of 27 days for assessments of amendments (within the statutory timescale of 35 days).
We have now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
More information about individual trial application status, is available by emailing clintrialhelpline@mhra.gov.uk.
 We would like to remind you that our consultation on statutory fees is still running and will close later in the month on 24 October. Please do make sure you submit your comments before the deadline. We would also like to encourage any micro or small-medium business to share their views, so that the consultation is as representative as possible. Find out more about the consultation and share your views
Implementing the new UK clinical trials regulations
Together with our partners, the Health Research Authority (HRA), we are hosting a short webinar on Tuesday 15 October 2024, from 2pm – 4pm to introduce our joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. Book your place now for Implementing the new UK Clinical Trials regulations Tickets, Tue, Oct 15, 2024 at 2:00 PM.
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We are calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulatory sandbox.
The AI Airlock is a world leading regulatory sandbox for AI as a Medical Device (AIaMD). This pilot project will help us identify and address the challenges for regulating AI medical devices so that in the future, innovative and safe AI medical devices can be brought safely into use in the shortest time possible, for the benefit of patients and the NHS.
During the AI Airlock programme, candidates will benefit from a bespoke testing plan and a unique collaboration with industry and regulatory experts, which will help them gain an improved understanding of the current regulatory framework and the data standards expected.
The call for applications is open for two weeks until Monday 7 October and will provisionally recruit candidates into the pilot covering a wide range of regulatory challenges, from different healthcare or clinical disciplines and at various stages of product and regulatory development.
Eligible candidates must be able to demonstrate that their AI-powered medical device has the potential to deliver benefits to patients and therefore the NHS, is a novel or innovative application, and can present a regulatory challenge that is ready to be tested in the Airlock pilot programme.
has We approved the new medicine fruquintinib (Fruzaqla) to treat adult patients with metastatic colorectal cancer (CRC). It is used when other treatments have not worked.
CRC is an abnormal growth of cells that begins in a part of the large intestine called the colon. When the cancer is metastatic, this means that it has spread to other parts of the body.
In patients with metastatic CRC, fruquintinib stops tumours from making new blood vessels and therefore slows down the growth of cancer. Blood vessels would usually provide the tumour with nutrients and oxygen.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
"Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review."
The application for approval was supported by evidence obtained via two main studies (FRESCO-2 and FRESCO). FRESCO-2 involved 691 adults with previously treated metastatic colorectal cancer. The study included patients who had disease progression on, or were intolerant to, chemotherapy, biologics, and trifluridine/tipiracil (TAS-102) and/or regorafenib.
We have recently published new guidance on the Early Access to Medicines Scheme (EAMS)
The new guidance is consistent with The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 and will provide clarity in areas such as robust documentation and processes, to help streamline and progress applications more quickly.
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