Guidance
Clinical trials for medicines: ending a clinical trial
Guidance on the process for ending a clinical trial.
Change of https://www.gov.uk/guidance/clinical-trials-for-medicines-ending-a-clinical-trial
Change description : 2025-10-01 13:43:00: Major update to guidance and diagram attachments [Guidance and regulation]
Showing diff : 2025-08-21 13:56:57.403730420 +00:00..2025-10-01 12:43:22.134304045 +00:00
Guidance on the process for ending a clinical trial.
This guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”), as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
These amendments come into force on 28 April 2026.
Until this date, this guidance is in draft and should only be used to support sponsors in preparing for the implementation of the new regulations. Please see Clinical trials for medicines: apply for authorisation in the UK and Clinical trials for medicines: manage your authorisation, report safety issues for the guidance that should be followed prior to 28 April 2026.
The following guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”), as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025... These amendments come into force on 28 April 2026. For assistance in determining whether a clinical trial is within the scope of these Regulations, see the Is it a clinical trial of a medicinal product? algorithm (please note that this document will be updated in due course).algorithm.
Part 2 of Schedule 1 to the Clinical Trials Regulations requires that the investigator and sponsor have regard to all relevant guidance with respect to commencing and conducting a clinical trial. Investigators and sponsors (and any individual or organisation that the sponsor delegates trial-related activities to) must, therefore, ensure that they are fully aware of the information within this guidance and act accordingly to achieve and maintain regulatory compliance.
Per regulation 27 of the Clinical Trials Regulations, the sponsor must provide written notice to the licensing authority that a clinical trial has ended (and this notice should also be provided to the ethics committee). This refers to the global end of the trial.
The notice must be provided within:
While local end of trial declarations can optionally be submitted, they will not be reviewed by the licensing authority and relevant safety updates and substantial modifications must continue until the global end of trial notification is received, unless agreed otherwise via a substantial modification.
If the clinical trial that has ended was:
After submission, an acknowledgement will be issued by email (and thoughthrough IRAS for combined review trials). No acknowledgement will be issued if the submission was related to the local end of trial.
For trials terminated in accordance with the protocol, details of where the results have been published in a public registry should be provided to the licensing authority and ethics committee within 12 months of trial completion (except for some paediatric trials involving the use of authorised medicinal products, see below).
For trials terminated prior to the date or event specified in the protocol:
Please note that where a deferral to the requirement to publish the results is in place, the sponsor should still provide a summary of the trial results to the licensing authority within 12 months of trial completion (which will be kept confidential). This may be required as a condition of approving the deferral
deferral.
If the trial is sponsored by the holder of a UK marketing authorisation and involves the use of that authorised medicinal product use in a paediatric population, the results must be submitted to the licensing authority within the 6 months beginning with the day on which the trial ended. The details of where the results have been published should still be submitted to the ethics committee within 12 months of trial completion.
Please note that once the global end of trial notification has been received by the authorities, it is not possible to submit any further clinical documents other than a summary of results (if the sponsor chooses to submit this).
Under regulation 25(2) of the Clinical Trials Regulations, within 12 months from the day after the conclusion of the trial, the sponsor must:
At any point before the 12-month deadline, sponsors may apply to the HRA for a deferral or waiver to one or both requirements, explaining why this is needed. Phase I clinicalsclinical trials may be eligible for an automatic deferral of up to 30 months from the conclusion of the trial, which may be further extended on request.
See detailed guidance from the HRA on on the requirement to registerpublish the results of a clinical trial.
Under regulation 17(2)(b) of the Clinical Trials Regulations, the licensing authority can take into account any outstanding failures to comply with regulation 25(2)(a) (unless a deferral or waiver has been approved by the ethics committee) when assessing future applications by the same sponsor.
Under regulation 26 of the Clinical Trials Regulations, a clinical trial approval will lapse two years from the date on which the trial was approved if no participants have been recruited (i.e. have signed the consent form) to take part in the UK trial.
The licensing authority and ethics committee (“the authorities”) will monitor the status of the trial’s approval. If the approval lapses, the sponsor will be contacted via email to confirm this. The sponsor will then need to submit an end of trial notification.
Sponsors can apply to the authorities for an extension of this period by emailing clintrialhelpline@mhra.gov.uk,clintrialhelpline@mhra.gov.uk, explaining both why the extension is needed and the length of the proposed extension.
The authorities can grant:
The authorities will respond to extension requests via email within calendar 30 calendar days or, if the trial is awaiting approval, at the same time as the outcome of the application for clinical trial approval is issued.
Major update to guidance and diagram attachments
Link to feedback questionnaire removed following closure of questionnaire.
First published.
2026-01-12 09:00
Added text stating that all sponsors will need to notify the authorities of the date on which the first participant was recruited through a MOID.
2025-10-01 13:43
Major update to guidance and diagram attachments
2025-08-21 14:55
Link to feedback questionnaire removed following closure of questionnaire.
2025-06-25 10:07
First published.