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The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA.

MHRA Newsletter December 2023

Please note this is an extract of the original bulletin.

Clinical Trials and Investigations Performance

The latest MHRA performance data shows that, since September, regulatory assessments for clinical trials are being completed in an average of 24 days for initial assessments (within the statutory timescale of 30 days) and an average of 21 days for assessments of amendments (within the statutory timescale of 35 days).

The MHRA streamlined processes to reduce the time taken to process clinical trial applications and eliminated backlogs. We have now embedded a range of changes into our standard working practice, and will build further on these changes with new legislative measures to make it easier and faster for applicants to gain approvals and to run clinical trials in the UK.

We are now additionally publishing performance data on clinical investigations for medical devices.

International recognition

Thank you to all those who attended our webinar on International Recognition; we have now published the eligibility checker, and the recording of last month’s event alongside further guidance to support preparations to adopt this new route to market which will open from 1 January 2024.

We have focused teams to ensure the delivery of the new International Recognition pathway, and will be setting up robust systems to ensure that the delivery of applications is within timelines.

Product approval announcements

We have continued work to publish announcements to coincide with the conclusion of regulatory assessments, delivering on a key objective as listed within our corporate plan to build public trust and understanding of our work.  These are issued simultaneously as outcomes are communicated to applicants, and we work in tandem with the company ahead of issuing press materials.  Products we have approved this month include a world first gene-therapy that aims to cure sickle cell disease and we are working on a number of exciting developments in this space for 2024.

Open Competition for funding Regulatory Science and Innovation Networks

MHRA are excited to be supporting a new initiative to drive regulatory science.  We have clearly set out our ambition to be an agile and enabling regulator for the benefit of patients everywhere, and to do this effectively we need to ensure we are considering future regulation of emerging technologies and healthcare innovations. We are therefore encouraging applications from academic institutions in the UK to respond to the UKRI competition to receive funding and be at the cutting edge of life sciences research.

Further information on areas of research MHRA are encouraging through the competition will be released in 2024; and will align with the themes of our soon to be published Science Strategy.

Tehelj