Transparency data

MHRA performance data for assessment of clinical trials and established medicines

Updated 15 May 2024

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

Clinical trials

The latest MHRA performance data shows that clinical trials applications continue to be handled within target statutory timescales.

Regulatory assessments for clinical trials have been completed in an average of 26 days for initial assessments (within the statutory timescale of 30 days) and an average of 26 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 with 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.

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

Established medicines

We publish data on numbers of regulatory assessments, 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 timeframes, as our established medicines: marketing authorisation application changes take effect. We will always prioritise applications according to public health need. We continue to engage with DHSC Medicines Supply Team on the minimisation of medicines shortages and work to develop our strategies to prevent shortages.

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 a decrease the overall number of applications within the backlog (over the statutory timeframe of 210 days).

In addition, this month we have made changes to the range of data we publish. Following discussions with the Department of Health and Social Care, we will no longer report on reliance data, instead replacing it with data about our International Recognition Procedure. We also now publish data on the most requested points of validation, including validation of applications, patient information quality unit (PIQU) and compliance reviews. All are complying with expected timeframes.

We have been working to adjust our approach for assessments, which have been optimised to maximise on the effectiveness and efficiency of the process changes implemented on 1 March and will begin a review of this process in June, with the intention to publish the results.  We encourage those with feedback on the process changes to contact us directly at info@mhra.gov.uk.  The process changes cover both procedures in progress and those about to be assessed, with the following major points:

1. Applications will be assessed for completeness.
2. Complete applications will be reviewed and determined, with additional questions being asked as needed. Incomplete applications will be refused.
3. Following one round of questioning, the application will either be approved or the advice of the Commission on Human Medicines (CHM) will be sought on refusal.
4. For applications in progress, we will perform one additional round of questioning to a maximum of two rounds prior to seeking CHM advice.[LS1]

The process change guidance is published alongside a webinar recording that runs through these changes.

We continue to process both initial assessments and responses for information. In our recent webinar hosted on 24 April, we requested that companies take the following actions:

• Prioritise responding to RFIs so we can make a final decision on the application
• Ensure that updated documentation is submitted for the application via new eCTD sequences
• Provide a marked-up comparison of the Summary of Product Characteristics (SmPC) that includes -
  • a comparison of the text contained within the Patient Information Leaflet (PIL) against the equivalent product information for the reference medicinal product (where appropriate)
  • any additional stability data that has been generated to support an increase in shelf life since the original submission and any updates to relevant documents to reflect this
• Provide updated GMP certificates and/or QP declarations (where needed)
• Use available checklists which support applicants to complete ‘right first time’ submissions.

All eligible national Marketing Authorisation applications submitted before 1 January 2024 that were awaiting first assessment have been converted from the national route to recognition pathways, to speed up our regulatory assessments, where applicants requested this.

In addition, we have hosted several webinars with enhanced information and guidance:

• Performance data and process change update webinar recording (24 April 2024)
• International recognition procedure webinar recording (November 2023)
• RegulatoryConnect webinar recording (12 March). Our new service that provides the capability to track applications and view live authorisation details.

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 where we provide direct further support to applicants and which are led by Julian Beach, Interim Executive Director of Healthcare Quality and Access, MHRA.