A series of measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with the aim to make it faster and easier to gain approval and to run clinical trials in the UK.
According to the UK government, the changes represent the biggest overhaul in UK clinical trial regulation in over 20 years, and are to be introduced with the aim of helping make the UK more competitive in attracting clinical research.
As part of the process, the measures will include an application review within a maximum of 30 days in general, with a maximum of 10 calendar days for a decision to be granted once the regulator has received any final information.
On the movement towards greater transparency, the legislative changes will introduce a legal mandate to register the trial in a World Health Organization (WHO) public register, and a requirement to publish a summary of results within 12 months of the end of the trial. In addition, the sharing of trial findings with participants in a ‘timely manner and suitable format’ will also be required by law.
New guidance will also be introduced to accompany the legislative measures, which will include steps to work in partnership with patients and the public, as well as to be representative of the diversity of people living in the UK.
Marc Bailey, MHRA chief science and innovation officer, said, “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. This will make the UK one of the best countries in the world to conduct clinical research and, get innovative medicines to the people who need them faster.”
The government noted in the announcement that the legislative changes are ‘aligned’ with the review of clinical trials being currently conducted.
The steps have arrived after the industry, led by the Association of the British Pharmaceutical Industry (ABPI), and the House of Lords both expressed concern regarding evidence that clinical research in the country had fallen behind rival countries over the last five years.
In response to the announcement of legislative changes, Richard Torbett, ABPI’s chief executive, said, “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centered on patient safety and the benefits of participating in research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”
