MHRA performance data for assessment of clinical trials and established medicines
Updated 15 January 2025
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Here we provide the MHRA performance data to December 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 (November 2024) report indicates that 99% 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 MHRA’s regulatory reforms and how these will benefit applicants.
Our webinar (15 October 2024), delivered with our partner 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
For 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), with decisions made for over 1680 licence applications in the year. We continue to make significant progress towards eliminating the remaining overdue applications, with a focus on completing assessments.
Variations
- Regulatory checks for all Type 1a variations submitted over the last month have been completed in an average of 18 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. 76% 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 licence applications for established medicines within expected timescales.
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We eliminated our original backlog (set in January 2024) in October 2024 and continue to make progress to conclude assessment of the applications which have fallen overdue since the original backlog was set.
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Applications submitted after the 1st September 2024 are being assessed within statutory timelines with decisions delivered by 210 days.
- Regulatory assessments for International Recognition Procedure (IRP) applications are being completed within statutory timeframes: an average of 55 days for route A (within the statutory timeframe of 60 days), and in an average of 90 days for route B (within the statutory timeframe of 110 days).
Understanding the performance data we publish
- Our monthly publication includes 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 of these non-statutory procedures are being completed within our expected timescales, resulting in the full assessment process for new applications being completed 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 have reviewed the effectiveness of these process changes and updated our guidance to clarify any changes.
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.
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.
- Processes to manage medicines supply disruptions webinar recording (7 November 2024). 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.