Transparency data

MHRA performance data for assessment of clinical trials and established medicines

Updated 15 July 2024

© Crown copyright 2024

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines--2

Here we provide the MHRA performance data including timelines for applications for clinical trials, marketing authorisations for established medicines and variations to existing approvals. Our aim is to help applicants with decision-making, based on our performance.

1. Clinical trials

The latest MHRA performance data shows that clinical trials applications continue to be handled within 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 27 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 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

2. Established medicines

We publish data on numbers of regulatory assessments completed?, 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 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 continue to see progress in reducing our backlog and meeting statutory timescales.

Variations

  • In spite of receiving a higher volume of Type 1B variation applications in June, we expect to process applications submitted in July within statutory timescales.
  • The volume of Type II variations significantly increased in June. Month on month, we have continued to reduce the number of pending applications that are outside of statutory timescales.

Established medicines

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

Since May 2024, we have made changes to the range of 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 have been working to adjust our approach for assessments of marketing authorisation applications, to maximise the effectiveness and efficiency of the process changes implemented on 1 March and continue to review this process alongside ongoing work with stakeholders.  We encourage those who wish to provide feedback on these process changes to contact us directly at info@mhra.gov.uk.  

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

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 information and support. Please register to receive further information about our publications and events.

Back to top