The UK government plans to make clinical trials easier in a bid to restore the country’s status as a preferred destination for groundbreaking studies.
(Bloomberg) — The UK government plans to make clinical trials easier in a bid to restore the country’s status as a preferred destination for groundbreaking studies.
In a fresh move that aims to kickstart the country’s faltering life sciences ambitions, the Medicines and Healthcare Products Regulatory Agency and research ethics reviews could be combined, making the application processes faster for drug manufacturers trying to bring new medicines to patients.
It is key measure among others proposed by the government and represents the biggest overhaul of in UK clinical trials regulation in more than 20 years.
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The number of clinical trials initiated in the UK fell by 41% between 2017 and 2021, according to a report published by the Association of the British Pharmaceutical Industry last year, which also found studies are slower to get started.
More than 2,000 responses to the consultation were submitted from around the world by patients, researchers, health care professionals, industry trade associations, academic institutions and individual pharmaceutical companies.
Other measures proposed include reviewing applications within 30 days, removing duplicative requirements, and allowing trials with a risk similar to standard medical care to be approved without a regulatory review. The government will also give guidance on diversity in trials, without imposing targets or quotas.
The reforms come a few days after Chancellor of the Exchequer Jeremy Hunt unveiled plans to fast-track the approval of new drugs. In the budget, the government gave the MHRA, the UK medicines watchdog, £10 million ($12 million) to explore partnerships with agencies overseas, including the US, Japan and elsewhere in Europe, to give the green light to drugs already approved elsewhere.
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