UNITED KINGDOM — The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new framework that aims to streamline the process for drugmakers to gain approval for new medicines and conduct clinical trials in the UK, including global “multi-site” trials.

The framework includes several measures, such as integrating the regulatory and ethics reviews of clinical trial applications.

This approach resulted in a pilot phase halving the approval time for studies and cutting the time from application to recruiting a first patient by 40 days.

The MHRA will also enforce a timeline for reviewing applications, with a maximum 30-day completion period and a 10-day limit for a decision once the regulator has received all final information.

The changes are intended to create a framework that’s adaptable, responsive to various trial types and innovative designs, and supportive of new trial methods such as decentralized trials.

According to a release, Marc Bailey, Ph.D., MHRA’s chief science and innovation officer, stated that “Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile.

This overhaul of the clinical trials legislation will do just this—it will move us away from a one-size-fits-all approach to the regulation of clinical trials and help to streamline approvals by removing granular and duplicative regulatory requirements.”

The U.K. is seeking to revamp trial and medicines regulations following Brexit. The new framework includes a legal obligation to register trials in a World Health Organization public registry and the requirement to publish a summary of results within 12 months of the trial’s conclusion.

The legislation also requires the sharing of trial findings with participants in a timely manner.

According to a report published by the Association of the British Pharmaceutical Industry (ABPI) last year, the number of studies initiated in the UK dropped by 41% between 2017 and 2021, with a similar decrease in cancer trials.

Additionally, the UK fell down the global rankings for late-stage clinical research, dropping from second to sixth in phase II trials and from fourth to 10th place in final phase III trials.

ABPI Chief Executive Richard Torbett stated that “the reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”

He added that the association looks forward to collaborating with the MHRA to make the UK a favorable destination for clinical trials.

The reforms will include a legal mandate to publicly register clinical trials and share summary results with research participants.

Emma Walmsley, the CEO of GSK, predicted that the UK was at a “tipping point” in its life science ambitions.

However, the industry is currently in dispute with the government over a substantial increase in the rebates paid to the NHS each year.

In addition, the Treasury has announced that it will provide the MHRA with £10 million (US$12.3 million) in funding to expedite access to innovative medicines for patients in need.

This news coincides with Novartis’ decision to cancel its well-publicized plans for a major UK trial of the cholesterol-lowering drug Leqvio as a primary prevention medication in patients with atherosclerotic cardiovascular disease.

The trial aimed to gain wider approval for the drug by demonstrating that it could prevent the first occurrence of major cardiovascular health issues in high-cholesterol patients, as part of a broader collaboration with the British health system.

The Swiss drugmaker said, “After careful evaluation, we have decided not to move forward with Orion-17. We continue to have very high ambitions for Leqvio.”

Instead, Novartis will conduct a different global trial with 14,000 volunteers, including those in the UK.

The decision to cancel the U.K. trial was due to several factors, including the COVID-19 pandemic, which made it difficult to progress with the trial.

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