The changes will aim to make it easier to gain approval and to run clinical trials in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will be introducing a series of measures aimed at streamlining clinical trials approvals in the UK.

The changes, which represent the biggest overhaul in UK clinical trials regulation in over 20 years, include a legislative requirement to publicly register clinical trials and share summary results with research participants, as well as guidance to help researchers recruit a diverse cohort of participants.

A timeline for completion of an application review within a maximum of 30 days will also be implemented by the MHRA, with a maximum of ten days for a decision to be granted once the regulator has received any final information.

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.”

Bailey added that the organisation will now work collaboratively with patients and the research community to “ensure these changes are implemented as quickly as possible”.

The changes follow a public consultation in partnership with the Health Research Authority and the Department of Health in Northern Ireland, and are hoped to be as ‘future-proof as possible’.

The Association of the British Pharmaceutical Industry issued a statement in response to the framework, with chief executive, Richard Torbett, saying: “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred 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.

The announcement follows the UK government awarding additional funding of £10m for the MHRA to help bring innovative new medicines and medical technologies to patients more quickly.

Over the next two years, the funding will support the development of a shortened process to speed up the approval process for treatments developed in the UK with the ‘greatest opportunity to meet the UK’s healthcare priorities’, such as cancer vaccines.

https://www.pmlive.com/pharma_news/mhra_to_introduce_new_uk_clinical_trials_framework_1490045