When the new regulations come into force on 28 April 2026, all clinical trials of investigational medicinal products (CTIMPs) submitted from this date will be expected to recruit their first participant in the UK within 2 years of the trial being approved (meaning when the trial received both authorisation from the MHRA and a favourable opinion from the Research Ethics Committee).
This will also apply to trials involving an advanced therapy medicinal product (ATMP).
If a trial recruits no participants within 2 years, the approval for the trial will lapse. In this scenario, the sponsor will have to end the trial and submit notification in writing by the date that the approval lapsed. Continuing to run a CTIMP after the approval has lapsed would be considered an offence under the regulations.
If a sponsor submits a CTIMP application before 28 April 2026, this expectation will not apply. This means the approval will not lapse if the trial does not recruit its first participant within 2 years.
Confirming the first UK participant has been recruited
Sponsors will need to confirm the date that the first UK participant in a trial is recruited. Sponsors will be able to do this by using the modification tool to submit a modification of an important detail which confirms the first recruitment has occurred.
Extending the 2 year timeframe
We understand that in some situations, recruitment for trials may be challenging. If a sponsor suspects that their trial will not recruit the first participant within the first 2 years, they may be able to extend this time period. They can request an extension in 2 ways:
- as part of the clinical trial application (if this extension is agreed, it will be communicated in the outcome of the application)
- if the trial has already been submitted, the sponsor can request an extension by emailing the MHRA at clintrialhelpline@mhra.gov.uk (once it has been considered and a decision is made, the sponsor will be notified within 30 calendar days. To make sure the request is processed in time the sponsor should submit it at least 31 calendar days before the end of the 2 year period)
The request for an extension should include the reason why it’s needed and how long of an extension is being sought. If the MHRA agrees an extension is appropriate and justified, they can extend the timeframe by up to an additional 3 years after the lapse date.
If an extension of an additional 3 years is given, this means the trial would have 5 years from the trial approval date to recruit its first participant.
Further extensions to the recruitment timeframe
If a trial is reaching the end of the extended period and needs a further extension, the sponsor can request it by submitting another written request to the MHRA by emailing clintrialhelpline@mhra.gov.uk.
The request should be made at least 31 days before the previously agreed extension period ends. It will then be considered, and a decision will be sent to the sponsor within 30 days. Each further extension that is agreed will be extended by up to 2 additional years starting from the end of the previously agreed extension period.
If the sponsor does not submit an extension request in time, or if an extension is not agreed, the approval for the trial will be considered to have lapsed once the end of the 2 year (or extension) period is reached. At this point, the sponsor will be expected to end the trial.