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Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK

Gain an insightful understanding regarding the current review timelines for clinical trial and amendment applications of the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Analysing MHRA Performance Clinical Trial and Amendment Applications in the UK

In 2023, assessment timelines for Clinical Trial Authorization (CTA) applications and substantial amendments by the MHRA were, in many cases, well beyond the statutory assessment timelines:

  • 30 days for the initial review of a CTA application
  • 35 days for the review of an amendment

Significant Improvements in 2024

However, review timelines have significantly improved in 2024, and continue to be handled within target statutory timescales (Table 1). Currently, regulatory assessments for clinical trials are completed within:

  • An average of 28 days for initial assessments
  • An average of 30 days for assessments of amendments

The MHRA has now made improvements in processing clinical trial applications into standard working practice. The agency is committed to continue making enhancements to make it easier and faster for applicants to gain approvals and to ensure the UK remains an attractive destination to conduct clinical trials.

New Notification Scheme

Furthermore, the MHRA launched a new notification scheme on 12 October 2023 to enable a more streamlined and risk-proportionate approach to processing initial CTA applications for some phase 4 and lower-risk phase 3 clinical trials.

CTA applications meeting the inclusion criteria will be processed within 14 days instead of the statutory 30 days.

Performance Data Overview

Month
Submission type
Assessed
Statutory timelines met
May 2024
Initial application
67
100%
May 2024
CTA Amendment
286
100%
April 2024
Initial application
57
100%
April 2024
CTA Amendment
350
100%
Mar 2024
Initial application
48
100%
Mar 2024
CTA Amendment
325
100%
Feb 2024
Initial application
68
100%
Feb 2024
CTA Amendment
284
99,7%
Jan 2024
Initial application
72
97,2%
Jan 2024
CTA Amendment
476
99,6%

Table 1. Number of clinical trial and amendment applications processed since December 2023
Source: Medicines and Healthcare products Regulatory Agency

QbD Regulatory Team Support

The regulatory team at QbD has been providing services to support clinical trial submissions for the past 8-10 years across a broad range of studies.

Our team is happy to collaborate closely to understand your business needs and objectives, offering specialized solutions to assist you in accomplishing them.

With our expert guidance, you can confidently navigate pharmaceutical regulations regarding the submission and maintenance of clinical trial authorizations in the UK.

Don’t hesitate to contact us if you need regulatory support.

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