Here we provide the MHRA performance data to January 2025, including:

• timelines for applications for clinical trials

• marketing authorisations for established and innovative medicines

• variations to existing approvals

Our 2024/25 business plan outlines our 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 30 days for assessments of amendments (within the statutory timescale of 35 days).

We contribute towards the publication of performance data in the UK Clinical Research Delivery Performance Indicators Report. The latest (December 2024) report indicates that 98% 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 an implementation period. Find out more about MHRA 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 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, with decisions made for over 1680 licence applications in 2024. We continue to make significant progress towards eliminating the remaining overdue applications, with a focus on completing assessments.

Variations

For January 2025 we have seen an increase of over 30% variations granted compared to last month, even with the effects of the holiday period and further submissions which had affected some processing times, in particular for Type 1a variations. This is now resolved and all variation applications received have been processed.  

Regulatory checks for all Type 1B variations submitted over the last month have been completed in an average of 14 days, with 99% completed within expected timescales.

We have continued to reduce the number of pending Type II variation applications that are outside of expected timescales. 86% of Type II variations last month were completed within expected timescales, with an average time to determination of 73 days.

Established medicines

• We are now assessing within expected timescales all new licence applications for established medicines received since 1st September 2024.
• We eliminated our original backlog (concluding the assessment of 1167 applications 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, which now sits at 166.
• Applications submitted after the 1st September 2024 are being assessed within statutory timelines with decisions delivered by 210 days.
• This month validation times for new marketing authorisation applications increased due to high volumes and the effect of the holiday period. Validation times increased to an average of 14 days for IRP validation and 19 days for National validation. As of early February, performance has returned to target levels (5 days for IRP and 14 days for National).
• Regulatory checks for International Recognition Procedure (IRP) applications are being completed within statutory timeframes: with an average of 57 days for route A (within the 60 day target) for our review in January 2025. The average timeframe for IRP route B applications is 103 days (within the 110 day target). 

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.
• The majority 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 continue to embed improvements in processing medicines licensing applications in standard working practice and will communicate further on this once our immediate priority to maintain 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. 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.