The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced several new measures to make it easier to run clinical trials in the country, marking the first time in 20 years the regulatory body has made such an overhaul.
The changes include integrating regulatory and ethics reviews of clinical trial applications, which in a pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days, the agency said in a March 21 release.
The MHRA will also implement a timeline for completion of an application review within a maximum 30 days with a 10-day limit for a decision to be granted once the regulator has received any final information. Such legislative changes are aimed at creating a framework that’s “as future-proof as possible, responsive to different types of trials and innovative designs, and supportive of new ways of carrying out trials such as decentralized trials.”
“Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile,” Marc Bailey, Ph.D., MHRA’s chief science and innovation officer, said in the release. “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 new framework also adds a legal mandate to register the trial in a World Health Organization public register and a requirement to publish a summary of results within 12 months of the end of the trial. The law includes the sharing of trial findings with participants in a timely manner.
Additionally, the Treasury announced it would grant the MHRA 10 million pounds sterling ($12.3 million) in funding to get innovative medicines to the patients who need them sooner.
The announcement comes the same week that Novartis scrapped well-publicized plans for a major U.K. trial of cholesterol-lowering drug Leqvio as a primary prevention med in patients with atherosclerotic cardiovascular disease.
By Joseph Keenan
Source: fiercebiotech.com
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