Transitional Arrangements for Clinical Trials
As previously posted within S-cubed news, new Clinical Trial Regulations in the UK will enter into force on 28 April 2026 which will ‘allow for a more proportionate, streamlined, flexible and effective clinical research environment’ in the UK.
To ensure continuity, detailed transitional arrangements have been published by the MHRA to distinguish between clinical trials submitted under the existing 2004 regulations (‘old rules’) and those under the amended 2025 regulations (‘new rules’).
Detailed Transitional Arrangements:
The transitional arrangements address several key areas:
Approval Process
Applications for clinical trials which are submitted before 28 April 2026 are considered old-rules clinical trials and will generally continue to be regulated under the 2004 regulations even if approval has not been received by this date, with notable exceptions as detailed in the below sections.
In contrast, applications submitted on or after 28 April 2026 are considered new-rules clinical trials and must comply fully with the amended regulations.
Transparency
Transparency requirements are partially extended to ongoing old-rules trials that have not ended before 28 April 2026. These trials will now need to follow the new requirements to register a trial within a public registry and publish the summary of results in the same registry.
New-rules trials must follow all of the transparency requirements in the amended regulations.
Good Clinical Practice
The latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will come into force in the UK on 28 April 2026 as part of the amended regulations, and will be applicable for both old-rules and new-rules trials.
The only difference between the two types of trial will be with regards to the retention of the trial master file, which will remain as 5 years for old-rules trials and extend out to 25 years for new-rules trials.
Amendments to the Trial
In comparison to the other areas concerned by transitional arrangements, the applicable regulations for changes to clinical trials are determined by the date on which the modification/amendment application is submitted, rather than whether the trial has been approved as an old-rules or new-rules clinical trial.
If an application for a substantial amendment is submitted before 28 April 2026, the existing regulations apply to the entire process, even if the decision is made after that date. In contrast, if an application is submitted after this date, even for old-rules trials, the amended regulations apply.
Safety Reporting and Pharmacovigilance
Much like the changes to GCP requirements, the amended regulations will apply to both old-rules and new-rules trials from 28 April 2026.
Sponsors of old-rules trials may elect to temporarily continue the trial under the previous pharmacovigilance framework until the submission of the first annual safety report after 28 April 2026 is made, at which point the amended regulations will apply.
Manufacture, and Importation & labelling
All investigational medicinal products (IMPs) manufactured or imported into the UK will be subject to the amended regulations from 28 April 2026, regardless of whether they are used in old-rules or new-rules trials. The only exception to this being the exemption to hold a manufacturing authorisation for radiopharmaceuticals used for diagnostic purposes which will not apply to old-rules trials.
IMPs manufactured in the EU or EEA and certified by an EU-Qualified Person (QP) before 28 April 2026 may continue to be imported and used under the transitional arrangements.
Labelling
The labelling requirements listed in the amended regulations will apply to all trials. IMPs manufactured and QP certified before 28 April 2026 can continue to be used after this date with their existing labels, however, IMPs manufactured and QP certified after this date must comply with the new labelling requirements.
Transitional arrangements do not apply to non-investigational medicinal products (NIMPs) and from 28 April 2026, all NIMPs must meet the new labelling requirements, regardless of the date of manufacture. Sponsors of existing trials using non-compliant NIMPs must submit a substantial amendment for approval of new or varied labelling at least 35 days in advance of this deadline.
Enforcement
Under the amended Regulations, the provisions against which an infringement notice can be raised or provisions that constitute an offence have been expanded. The enforcement measures that will apply after 28 April 2026 depend on the actual provision that has been breached:
- If a breach involves a provision in the amended Regulations, enforcement will follow the measures stated in the amended Regulations.
- If a breach involves a provision in the existing regulations the existing enforcement measures will apply.
How can S-cubed help you?
S-cubed can support with the transition to the new Clinical Trial Regulations and prepare and coordinate all the necessary regulatory documentation you may require for a CTIMP or IMP/Device application in the UK, including authoring IMPDs and IBs and ensuring these meet the relevant UK requirements. We can also support the submission of a trial application through to determination, and throughout the life-cycle of the trial.
Any Questions?
If you have any questions on this topic, please don’t hesitate to ask. You can contact us here, via email (info@s-cubed.co.uk), and telephone (S-cubed Ltd: +44 1235 77 22 60).