The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) expects the new UK clinical trial regulation to be implemented by January 2026.
In a webinar on 15 October, MHRA chief executive Dr June Raine said the new Labour Government had endorsed proposals set out in the MHRA’s consultation response published in 2023. The government noted that clinical trials will play a key role in developing the UK’s life sciences ecosystem.
Raine went on to share that the MHRA intends to lay in parliament the new clinical trials legislative framework before the end of 2024.
Between 2022 and 2023, the MHRA undertook a consultation period surrounding a new legislative framework for clinical trials in the UK.
The MHRA said the new regulation will ensure patients and their safety are the focus of all clinical trials, while bringing the benefits of clinical trials to everyone. The new regulatory framework will be “streamlined, agile and responsive to innovation”, and create a proportionate and flexible regulatory environment around new science and technologies being developed in the UK, cementing the nation’s position as a destination for international trials.
Freya Newton, principal policy specialist at the MHRA, commented: “We have gained ministerial approval to continue with our plans to reform the clinical trial regulations, so we have continued with the legal drafting in line with the proposals set out in the public consultation, and that is currently in the final stages of legal checks and parliamentary processes that need to take place.
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By GlobalData“The aim is to lay the legislation in November this year, after which, parliamentary debates will take place. We are currently predicting that the new regulations will be implemented in January 2026, but this will depend on when the regulations are debated and then passed,” Newton continued.
The broad range of changes the new regulation will bring
With a view to bolstering the UK’s appeal as a destination for clinical trials, the plans for the new regulation are extensive.
They include changes to the approval process to simplify and streamline the approval of clinical trial applications. The plans would see a single application route into the legislation with a coordinated regulatory and ethics review, which the MHRA said will lead to a single UK decision for a clinical trial.
The review timelines for applications are also set to be updated to ensure flexibility and competitiveness, with hopes that a combined decision will be issued within 30 days post-validation.
“During the approval process, a notification scheme for initial clinical trial applications will also be embedded in legislation, to enable a more streamlined and risk proportionate approach, and that will reduce the time to get lower risk clinical trials up and running without undermining patient safety,” Newton said.
The new regulation will also bring changes to areas including research transparency and good clinical practice (GCP).
Regarding research transparency, the MHRA said a legislative requirement would be introduced for trials to be registered on a public registry before they begin, with a summary of results to be published within a year of the trial ending.
“Sponsors may request a deferral of these transparency requirements to protect commercial or confidential information, or in exceptional circumstances, may also request a waiver,” Newton noted.
Currently, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for GCP are followed where trials are conducted to support a marketing authorisation, but Newton noted that this is not currently a UK legislative requirement.
“The new legislation will require compliance with the overarching principles of GCP,” Newton said. “This would update the provisions on GCP to align with the principles of ICH guidelines. This will ensure international standards are met and UK clinical trial data is accepted globally.”
In closing, James Pound, interim executive director, innovation and compliance at the MHRA, said the authority remained committed to having a thorough process of engagement with industry around the legislative guidance to ensure it is fit for purpose from day one of its implementation.
“But clearly, we all learn over time, so it would only be sensible to say the approach will be to further develop the guidance as we learn,” Pound said.
“With previous MHRA guidance in mind, we clearly go through revisions over time to make sure we better clarify information and ensure that people understand what they need to be doing to comply with regulatory requirements,” he concluded.
