The countdown to the new regulations for clinical trials has begun. The regulations come into effect on 28th April 2026.
The MHRA and HRA (Health Research Authority) have created a Clinical Trials Hub where all of the new guidance is being uploaded – this can be found here:
https://www.gov.uk/government/collections/medicines-clinical-trials#guidance—from-28-april-2026
The new regulations will provide a combined review and streamlined approval route for applications. A single application (including the documentation) can be submitted through the Integrated Research Application System (IRAS) and this will be reviewed jointly by the licensing authority and a research ethics committee (REC).
Applications for authorisation of a clinical trial received on 27th April or earlier, ‘old rules’ will apply. Applications for authorisation of a clinical trial received on 28th April or after, ‘new rules’ apply.
Below is a selection of the summary of changes in the new regulations (taken from the webinar which took place on 12th March 2026)
Applying for a clinical trial approval
- Combined MHRA and REC review introduced into legislation (with option for independent submission in exceptional circumstances)
- 60-day timeline to respond to RFIs (or other timeline agreed with authorities)
- 10-day timeline for decision after RFI response received
- Where an application needs expert advice:
- 90-day extension to timeframe for assessment
- 30-day extension for assessing RFI response
- 60-day extension for assessing RFI response if the product is an ATMP
- Notifiable trials introduced into legislation
Safety and Pharmacovigilance
- Removed requirement for individual SUSARs to be reported to all investigators
- Removed requirement for individual SUSARs to be reported to REC
- Removed requirement for DSUR to be sent to REC
- Introduced requirement to include appropriate evaluation of SAEs and SARs in the DSUR, with or without line listings
- Introduced timeline for DSURs of 60 days from end of reporting year
- Timeline for written notification for USMs extended from no later than 3 days to no later than 7 days
- Regulatory action can be taken against a specific part of a trial rather than the whole trial
Other Changes
- Changed GCP principles to align with ICH GCP
- Extended list of roles who can be a PI
- Confirmed that CT requirements apply to laboratories and computerised systems used for trials
- Change labelling requirements
- Re-introduced non-investigational medicinal products
- Introduced undertaking to permit overseas inspection
- TMF and medical records retention period increased
So now is the time to start updating SOPs, PV systems, USM workflows and begin training for employees in the new regulations.
A recording of the webinar ‘CT regulations: Countdown to implementation’ is now available and can be found here:
https://www.gov.uk/guidance/clinical-trials-regulations-webinar-recordings
If PCL can be of any assistance, please contact us.