Guidance
Clinical trials for medicines: expert advice
Clinical trial applications that need expert advice from a specialist group or committee.
Change of https://www.gov.uk/guidance/clinical-trials-for-medicines-expert-advice
Change description : 2025-10-01 13:41:00: Major updated to guidance and diagram attachments [Guidance and regulation]
Showing diff : 2025-08-21 13:54:58.814427452 +00:00..2025-10-01 12:42:02.919699791 +00:00
Clinical trial applications that need expert advice from a specialist group or committee.
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.
The licensing authority and ethics committee (“the authorities”) may consult with a relevant committee or specialist group on an application for clinical trial approval before issuing a decision.
While expert advice can be sought about any clinical trial, the authorities will consider factors such as the investigational medicinal product (IMP)’s mode of action, the nature of the target, and the relevance of animal species and models when determining whether to consult a committee or specialist group.
A non-exhaustive list of circumstances in which expert advice may be needed is as follows:
Prior to submitting an application for clinical trial approval, the applicant should use the criteria above to assess whether their trial may need to be reviewed by a specialist group or relevant committee. If unsure, contact the licensing authority for advice by emailing clintrialhelpline@mhra.gov.uk with a summary of the nature of the compound, its target and mechanism of action, and the relevance of the animal models. While the licensing authority will provide an opinion based on the information provided, it is possible that this may change following review of the full application and expert advice may then be sought.
If the applicant believes that expert review is required, they should:
Where a specialist group or committee is consulted, the maximum timeline for the authorities to issue a decision on clinical trial approval is extended by 90 calendar days (to 120 calendar days from the date of validation). The combined decision will be issued through IRAS through the same process as for trials not identified as requiring expert advice.
If the application identified as needing expert advice is an application for clinical trial approval that has been amended following a request for further information, the 10-calendar day timeline for the authorities to issue a decision is extended by 30 calendar days (to a maximum of 40 calendar days from receipt of the further information or amended application), unless the IMP to be used in the clinical trial is an advanced therapy medicinal product, in which case the timeline is extended by 60 calendar days (to a maximum of 70 calendar days from receipt of the further information or amended application).
The timelines associated with obtaining expert advice on an application for clinical trial approval are summarised in the figure below. This diagram shows the maximum possible timelines (except the time between submitting the application and the expert advice meeting). The time to a decision will be shorter than this for almost all applications. Please note that:
If the applicant does not identify that expert advice may be needed, but the licensing authority or ethics committee determines during their review that it is, the applicant will be informed within 30 calendar days of validation and asked to provide information (as above) to facilitate the experts’ discussion.
Extensions to timelines are the same regardless of whether the need for expert advice was identified by the applicant or the authorities.
Major updated to guidance and diagram attachments
Link to feedback questionnaire removed following closure of questionnaire.
First published.
2026-01-12 09:00
Changed date for submission of application to 28 days before CTBVEAG meeting from 14 days. Corrected timeline error in the publication ‘Flowchart summarising the process of applying for clinical trial approval for applications requiring expert advice’.
2025-10-01 13:41
Major updated to guidance and diagram attachments
2025-08-21 14:54
Link to feedback questionnaire removed following closure of questionnaire.
2025-06-25 10:07
First published.