MHRA performance data for assessment of clinical trials and established medicines
Updated 15 April 2024
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Here we provide the MHRA performance data for clinical trials and established medicines applications for the month of March 2024. Our aim is to help applicants understand the MHRA’s timelines for decision-making in relation to applications for clinical trials and marketing authorisations for established medicines and variations to existing approvals.
Clinical trials
The latest MHRA performance data shows that clinical trials applications continue to be handled within target statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 27 days for initial assessments (within the statutory timescale of 30 days) and an average of 25 days for assessments of amendments (within the statutory timescale of 35 days).
The MHRA has now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
More information about individual trial application status, is available by emailing clintrialhelpline@mhra.gov.uk
Established medicines
We publish data on numbers of regulatory assessments determined, average timescales at each stage, percentage within target and work on hand.
We continue to make significant steps towards assessing applications for medicines approvals within statutory timeframes. We will always prioritise applications according to public health need. We continue to have a very close engagement with DHSC Medicines Supply Team on minimising medicines shortages.
This month we have seen an increase in the number of applications processed, percentage of applications granted within the target timeframe and decrease in overall applications within the backlog (over the statutory timeframe of 210 days). Our prioritisation strategy ensures that applications are taken in order of validation date, except for applications for products that can meet public health needs, for example to prevent shortages or first generic products.
The process change introduced on 1 March 2024 aims to ensure applications are complete on submission or as soon after submission as possible. This new process change has the potential to reduce timelines substantially.
The process change covers both procedures in progress and those about to be assessed, with the following major points:
- Applications will be assessed for completeness.
- For complete applications these will be reviewed and determined, with additional questions being asked as needed. Incomplete applications will be refused.
- Following one round of questioning, the application will either be approved or the advice of the Commission on Human Medicines (CHM) will be sought on refusal.
- For applications in progress, we will perform one more round of questioning to a maximum of two rounds prior to seeking CHM advice.
The process change guidance is published alongside a webinar recording that runs through these changes.
To further improve the speed of our regulatory assessments, we request that wherever possible, eligible national Marketing Authorisation applications submitted before 1 January 2024 that are awaiting first assessment are converted from the national route to recognition pathways. Applicants should email MHRAEMreply@mhra.gov.uk to register interest in this option.
The measures we are putting in place are already resulting in significant improvements, and we will continue to publish monthly updates providing applicants with transparent information on expected timescales.
Finally, we are committed to providing applicants with information and support. Please register to receive further information about our publications and events where we provide direct further support to applicants and which are led by Julian Beach, Interim Executive Director of Healthcare Quality and Access, MHRA.