Transparency data

MHRA performance data for assessment of clinical trials and established medicines

Updated 15 October 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 28 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, 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.

Further information about the regulatory reforms we are introducing to the UK’s clinical research sector will be published in the near future.

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

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 report further progress in reducing our original backlog by 95% (concluding the assessment of 1109 out of 1167 applications).  We have 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 to 33% (from 43% last month).

Established medicines

  • We are now assessing all new applications within expected timescales.

  • Progress continues to be made in the determination of marketing authorisation applications for established medicines that are outside of statutory timescales.
  • International Recognition Procedure applications continue to be on track with 100% of our decisions coming within statutory timescales.

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.
  • 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:

 The MHRA’s  pipeline and portfolio gathering process which we are encouraging all current and future Market Authorisation Holders for medicines to participate in. This allows the MHRA to build our resource, resulting in applications being assessed with expert scientific rigour and within predictable timeframes.  A recording of the recent (26 September 2024) webinar will be uploaded shortly.

Our licensing webinar to cover processes to manage medicines supply disruptions on 7 November is open for registration. This jointly presented webinar will provide 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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