Transparency data

MHRA performance data for assessment of clinical trials and established medicines

Updated 20 November 2024

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Here we provide the MHRA performance data to October 2024 including timelines for applications for clinical trials, marketing authorisations for established and innovative medicines and variations to existing approvals.

Our 2024/25 business plan outlines the MHRA’s key performance indicators (KPIs) as part of our work to ensure greater transparency and accountability for our services.

Our aim is to help applicants with decision-making, based on our performance.

1. Clinical trials applications

The latest MHRA performance data show that clinical trials and investigations applications continue to be handled within statutory timescales.  Since September 2023, all clinical trial applications have been assessed within 30 days, with no backlogs.

Regulatory assessments for clinical trials have been completed in an average of 28 days for initial assessments (within the statutory timescale of 30 days) and an average of 29 days for assessments of amendments (within the statutory timescale of 35 days).

We contribute towards the quarterly publication of performance data in the UK Clinical Research Delivery Performance Indicators Report.  The latest (September 2024) report indicates that 95% of trials are currently receiving  a combined review decision within 60 days, measured from IRAS submission to combined MHRA and Research Ethics Committee regulatory decision.

The MHRA has now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements, and are introducing 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. Pending parliamentary process, we are aiming to lay the legislation by the end of the year.

Our recent webinar (17 October 2024), delivered with our partners, the HRA, provided further information about our plans to implement the regulatory reforms we are introducing to the UK’s clinical research sector, and we continue to engage the life sciences and research community in our work.

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. We have recently updated the criteria to reflect our commitment as a pragmatic regulator to proactively mitigate risks in line with best practice and patient safety.  Register your interest.

More information about individual trial application status, is available for applicants by emailing clintrialhelpline@mhra.gov.uk

2.  Medicines licence applications

We publish data on numbers of regulatory assessments completed, average timescales at each stage, percentage within target and work on hand.

The latest MHRA performance data show that we continue to make significant steps towards assessing applications for all medicines approvals within statutory timescales as our established medicines: marketing authorisation application changes take effect.

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.

This month we have reached a significant milestone in eliminating our original backlog of national marketing authorisation applications by 100% (concluding the assessment of 1167 applications, as established in January 2024).  Last month we amalgamated the presentation of the data into one single reporting field to enable applicants to better understand our progress towards eliminating the small number of remaining overdue applications.

Variations

  • We have cleared our backlog of overdue Type 1b variations and Regulatory assessments for all Type 1b variations submitted over the last month have been completed in an average of 13 days (within the statutory timescale of 30 days).
  • We have continued reducing the number of pending Type II variation applications that are outside of expected timescales.

Established medicines

  • We are now assessing all new applications within expected timescales.
  • We have eliminated our original backlog (set in January 2024) and continue to make progress to conclude assessment of the applications which have fallen overdue since this point, with clearance of assessment our current focus.
  • International Recognition Procedure applications are concluding assessment within an average of 58 days for route A.
  • For International Recognition route B, whilst the data shows 50% of applications falling outside of statutory timescales, this is due to requesting additional information from applicants to complete regulatory reviews.  We are considering how best to reflect this in performance data reporting going forward. This has impacted performance for a small number of applications in September, October and (expected) November 2024. 

Changes to the performance data we publish:

  • We no longer report on Reliance data, instead providing data about our performance in the International Recognition Procedure including innovative medicines (NAS – new active substances).
  • We now publish data on the most requested information relating to timescales for validation, including validation of marketing authorisation and variation applications, patient information quality unit (PIQU) and compliance reviews. All these procedures are complying with expected timescales, and trade associations advise these timescales being met should be used by applicants as indicators that MHRA are on track to complete all new assessments within statutory timeframes.
  • We no longer publish information on the clearance rates of the original backlog of established medicines (as set in January 2024) but on the single overdue applications figure.

We have been working to maximise the effectiveness and efficiency of the process changes implemented on 1 March and continue to review these changes alongside ongoing work with stakeholders.  We intend to embed improvements in processing medicines licensing applications in standard working practice and will communicate further on this once our immediate priority to restore performance to predictable and statutory timeframes is complete.  We have reviewed the effectiveness of these process changes and updated our process changes guidance to clarify any changes.

MHRA webinars with enhanced information and guidance to support applicants are available online:

Our licensing webinar to cover processes to manage medicines supply disruptions took place on 7 November and a recording will be uploaded to this website in the coming weeks. This jointly presented webinar together with DHSC and NHSE provided an overview of how the healthcare systems work collaboratively to manage medicine supply to the benefit of patients.

The measures we have put 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 general information and support. Please register to receive further information about our publications and events.

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