MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials

A new scheme from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to cut the approval time for the lowest-risk clinical trials in the UK by over half. The new Notification Scheme is based on that outlined in the MHRA’s clinical trials consultation, which was endorsed by 74 percent of those who responded.

It forms a significant part of the regulator’s overhaul of the clinical trials regulation announced in March 2023, which aims to make the UK a prime location for conducting clinical trials.

Eligibility of clinical trials under the MHRA’s new Notification Scheme

MHRA’s Deputy Director of Clinical Investigations and Trials, Andrea Manfrin, shared with EPR that the scheme “enables a more streamlined and risk-proportionate approach to processing Clinical Trial Authorisations (CTAs) for initial applications in Phase III and IV trials”.

The lowest-risk of these trials will be processed by the MHRA within 14 days instead of the statutory 30 days. This will be the case if the trial sponsor can demonstrate the trial meets the MHRA’s criteria, such as safety issues of the investigational medicine.

According to the MHRA, about 20 percent of UK initial clinical trial applications are expected to be eligible for the Notification Scheme.

Certain criteria are applicable to the new scheme. Clinical trial amendment applications will not be eligible. An opinion from a research ethics committee will remain a requirement for eligible trials, the agency added.

MHRA’s Chief Executive, Dr June Raine, highlighted that when considering the best interests of patients, clinical trial sponsors should use the new scheme “for all eligible trials”.

In communication with EPR, Manfrin stated that under the new scheme, patients will have “faster access to potentially life-saving medications that can be licensed more quickly, benefiting the global pharmaceutical industry”.

Manfrin told EPR that a key challenge in developing the scheme was “ensuring a robust process for measuring the scheme’s success. To address these challenges, the scheme will be conducted in several phases to ensure a thorough evaluation, particularly for patient safety which is our top priority and scalability of the proposal.”

Supporting the future of UK clinical trials

“We are delighted to support the MHRA with this new scheme. Combined review has already reduced the time taken to review clinical trials to half what it was five years ago, and we are keen to explore how the UK’s fast-track Research Ethics Service can complement the new notification scheme to further accelerate high quality health and social care research,” noted Dr Janet Messer, Director of Approvals at the Health Research Authority.

MHRA concluded that criteria for notification of clinical trials will continue to be reviewed. In the future, there is potential for the scheme to be expanded to some medium-risk clinical trials, the agency declared.