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 Group 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.
References
- Government Response to the Review into Commercial Clinical Trials
- MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
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