Transparency data

MHRA performance data for assessment of clinical trials and established medicines

Updated 13 December 2024

Here we provide the MHRA performance data to November 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 data.

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.

The new Clinical Trials Legislation was laid in Parliament on 12 December 2024 and will come into force following a 12-month implementation period.  Find out more about regulatory reforms and how these will benefit applicants.

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  are having an impact.

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.

We have eliminated our original backlog of national marketing authorisation applications (concluding the assessment of 1167 applications). We continue to make significant progress towards eliminating the remaining overdue applications, with a focus on completing assessments.

Variations

• Regulatory assessments for all Type 1a 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 to significantly reduce the number of pending Type II variation applications that are outside of expected timescales. 68% of Type II variations last month were completed within expected timescales, with an average time to determination of 73 days, (within the statutory timescale of 60,90 or 120 days depending on complexity).

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.

• International Recognition Procedure (IRP) applications are concluding assessment within an average of 60 days for route A, and within a maximum determination of 118 days for route B.

• Year to date performance of IRP applications has seen 96% of all applications processed within the expected timescales.  Performance for November has been impacted following requests-for-information (RFIs) where information was not supplied as requested or before, during the procedure. A maximum time of determination has been published in this month’s data, indicating the limited extent of the impact.

Understanding the performance data we publish:

• 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 taken by applicants as indicators that MHRA is on track to complete all new assessments within statutory timeframes.

• 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:

• Performance data and process change update webinar recording (24 April 2024). This covers our request to companies to take proactive steps to support their applications.
• International recognition procedure webinar recording (23 November 2023 and April 2024) This provided information to increase potential applicants knowledge and understanding of the guidance and updates for the new route.

• RegulatoryConnect webinar recording (12 March 2024). This discussed our new service that provides the capability to track applications and view live authorisation details.

• Pipeline and portfolio gathering webinar recording (26 September 2024).  This introduced 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 us to plan our resource, resulting in applications being assessed with scientific rigour and within predictable timeframes. 
• 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 medicines 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.