Clinical Trials Regulations enforcement provisions
Updated 19 March 2026
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Legal status of this guidance
The following guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. These amendments come into force on 28 April 2026, and any reference to ‘the amended Clinical Trials Regulations’ in this guidance should be construed as referring to the amended version.
For assistance in determining whether a clinical trial is within the scope of these Regulations, refer to the Is it a clinical trial of a medicinal product? algorithm.
Part 2 of Schedule 1 to the amended 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.
Background
The MHRA uses a system of seeking compliance, which escalates through actions which can be managed during the inspection process through to recommendations for regulatory action and issuing of infringement notices.
Criminal prosecution is used only as a matter of last resort. This supports the MHRA’s efforts as a pragmatic regulator to resolve issues without resorting to legal action but enabling us to do so if required.
Under the amended Clinical Trials Regulations, the provisions against which an infringement notice or an offence can be raised have been expanded, primarily to reflect changes in legislation as a result of this revision, but also to bring the ability to issue infringement notices against the same provisions which, if contravened, constitute an offence.
The list of provisions can be found in Regulation 48 (‘Infringement Notices’) and Regulation 49 (‘Offences’).
Significant additions
Sponsors and applicants should be aware that notifications of an important detail or making a modification request to the MHRA or ethics committee which contain false or misleading information may have action taken against them.
New offences associated with non-investigational medicinal products, the notification scheme, record keeping associated with serious adverse events and reactions, transparency requirements and lapse of clinical trial approval have been created.