The safety reporting requirements for clinical trials of investigational medicinal products (CTIMPs) have changed.
The new requirements apply to all CTIMPs whether they were submitted before or from 28 April 2026.
The sponsor of a clinical trial approved before this date may elect to have the trial temporarily continue in compliance with the previous legislation's safety reporting requirements.
Requests for this will need to be made to the Medicines and Healthcare products Regulatory Agency (MHRA).
Please see the MHRA's guidance for transitional arrangements for the new clinical trials regulations which includes information on this and how you can request it.
Suspected unexpected serious adverse reactions (SUSARs) and annual safety reports
From 28 April 2026, SUSARs and annual safety reports for all CTIMPs (whether they were submitted via Combined Review or not) should only be reported to the MHRA. If any ethical issues are identified by the MHRA when they receive these reports, they will liaise with the REC directly.
For further information on how to submit these to the MHRA, and the timeframes for doing so, read the MHRA's guidance.
Urgent safety measures (USMs)
From 28 April 2026, the period a sponsor has to give written notice to the REC and MHRA for a USM they take has been extended from 3 to 7 days.
The process which sponsors follow to give written notice to a REC of a USM remains the same. This means that if any of the trials relating to the USM are submitted through Combined Review, the sponsor should submit the notice of the USM through the Integrated Research Application System (IRAS). However, if all the trials relevant to the USM are not submitted through Combined Review, the sponsor should notify the REC by email. In all cases the sponsor should make sure the notification clearly explains that measures have been taken and the reasons why.
If a USM requires a change to study documents this should be submitted as a modification as soon as possible. The modification submission should be identified as being in response to a USM and should include a copy of the USM notification.
Please see the MHRA guidance on safety reporting on how to notify the MHRA of a USM.