Euro Roundup: MHRA advances major overhaul of UK clinical trial regulation after positive feedback

The Medicines and Healthcare products Regulatory Agency (MHRA) has committed to embarking on the UK’s “biggest overhaul of trial regulation in 20 years” after a consultation revealed support for many of the draft proposals.

At the start of 2022, MHRA sought feedback on proposals to take advantage of the UK’s split with the EU and “deliver a world-class sovereign regulatory environment for clinical trials.” The goals of the proposed legislative amendments included streamlining the regulation of clinical trials and reducing “unnecessary burden to those running trials by taking a risk-based approach.”

One year after closing the consultation, MHRA and the UK government have shared their response to the feedback they received from 2,138 respondents. The UK is advancing most, but not all, of the proposals in light of the support they received in the consultation.

Through the reforms, the UK will combine MHRA and ethics reviews and aim to complete assessments within 30 days of the validation of the application. Combining the reviews halved the review time, and reduced the time from application to first patient in, during a pilot phase. The new legislation will set the review time at 30 days and give MHRA 10 days to make a decision after further information is submitted.

Two-thirds of respondents supported combining the reviews, with another 16% expressing no opinion. Some respondents suggested that the UK should mirror the equivalent EU timeline. The government rejected the proposal because “the timelines set out in the EU regulation ... are significantly longer and less flexible than those we have proposed.”

MHRA will pursue certain changes to safety reporting despite the consultation revealing mixed opinions. Almost half (46.2%) of respondents disagreed with plans to remove the requirement to report individual suspected unexpected serious adverse reactions (SUSARs) to all investigators, noting that the proposal “would limit the access of investigators to relevant safety information in real time.”

The government refuted the concerns, noting that “there are other ways investigators receive safety information” and speculating that “many of the responses disagreeing with this proposal may have been based on a misunderstanding of the current procedure.” In the government’s view, the change removes a duplicative legislative requirement. The reform and other contentious SUSAR changes are going ahead.

Based on feedback, the government has dropped plans to:

enable regulators to take into account previous information of non-compliance when considering a new clinical trial application;
require clinical trial populations to reflect the diversity of the UK;
mandate the involvement of patients and caregivers in clinical trial design; and
change the rules on the collection of data following MHRA approval for use of an unlicensed medicine.

Guidance on the diversity of study populations is planned, and legislation to support the Early Access to Medicines Scheme has already delivered on MHRA’s objectives for the unlicensed medicine proposal.

The government is drafting the necessary legislation to enact the changes.

Press Release, Consultation Response

EMA outlines achievements of its Regulatory Science Strategy to 2025

The European Medicines Agency (EMA) has posted an overview of the progress it has made over the first 1,000 days of its Regulatory Science Strategy to 2025. EMA’s mid-term report details achievements related to fostering innovation in clinical trials, promoting real-world data (RWD) and more.

In 2018 and 2019, EMA developed a strategy intended to ensure regulations kept pace with innovation. The agency has now passed the halfway point its plan.

“What is remarkable about this report is to reflect on what has actually been achieved during this immensely challenging period for the European Regulatory Network and how far the strategic goals and underlying recommendations have been progressed,” the agency wrote.

Working on the top five recommendations for its human medicine units, EMA has launched the Clinical Trial Information System, established Accelerating Clinical Trials in the EU, founded RWD initiative DARWIN EU and provided input to the Innovative Health Initiative.

EMA also shared details of its efforts to support the translation of advanced therapy medicinal products into patient treatments, promote its PRIME scheme, facilitate implementation of novel manufacturing technologies and create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products.

EMA Report

EMA publishes annual reports on independence and EudraVigilance, tracks fall in safety cases

EMA has published its annual reports on EudraVigilance and independence. After the pandemic-driven surge in reports related to suspected adverse drug reactions (ADRs) in 2021, the level of EudraVigilance activity fell last year while still remaining above historical levels.

Mass-vaccination campaigns against COVID-19 made 2021 a record year for reports of suspected ADRs. The number of reports fell 18% to 2.9 million last year. COVID-19 vaccines accounted for 1.1 million (39%) of the reports. EMA said its pharmacovigilance system “remained efficient in detecting and processing suspected safety issues” while operating under a load that exceeded pre-pandemic volumes.

Based on the reports, EMA produced more than 23,000 statistical outputs and screened for signals that were subsequently assessed by the Pharmacovigilance Risk Assessment Committee (PRAC). As was the case in 2021, almost 25% of signals discussed at PRAC last year related to COVID-19 vaccines.

In the independence report, EMA describes one breach of trust procedure that concluded last year and found that the committee member’s failure to declare a financial interest was accidental and not due to gross negligence. The report also describes recommendations for further improvements, some of which relate to the new policy for scientific committees’ members and experts that took effect in January.

EudraVigilance Report, Independence Report

EMA discusses mandatory use of CTIS, plans enhancements

EMA has used the first meeting of its management board since it became mandatory to use the Clinical Trials Information System (CTIS) for initial applications to outline planned improvements to the platform.

At the meeting, EMA noted it plans system releases for the first quarter of 2023 and is working to support sponsor and member state users of CTIS through training, information events and the publication of related materials.

The board also discussed the work of EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products. The steering group recently discussed plans to mitigate antibiotic shortages during the upcoming cold and flu season. EMA “will liaise with key manufacturers to discuss manufacturing capacity and forecasts of demand for a selected group of critical antibiotics.”

The planning follows a winter in which EMA provided regulatory support to increase production capacity for the antibiotic amoxicillin and encouraged member states to consider national regulatory flexibilities to allow the distribution of medicines that are not authorized within their borders.

Meeting Highlights

Euro Roundup: MHRA advances major overhaul of UK clinical trial regulation after positive feedback

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