I’ve seen various interpretations of the impact to clinical labeling requirements for the UK pertaining to the amendment to the UK CTR, which is applicable to lots certified after 28-APR-2026.

In particular, in one assessment the term “subject” will no longer be accepted on clinical labeling for the UK in factor of “participant.”

In my original reading late last summer of the information that’s been shared (which admittedly may not have been exhaustive) I found no strict requirement to switch labeling to reflect the term ‘participant,’ although the amendment obviously favors it strongly. Recent recommendations received from a large CMO organization we work closely with suggests otherwise.

Particularly in terms of updated and replacing booklet label inventory, making this change would be costly and resource intense in the short term.

I’d appreciate your sharing assessments and justifications regarding how you’re handling this in your organization.

https://www.gov.uk/guidance/clinical-trials-for-medicines-labelling#labelling-for-investigational-medicinal-products-imps-used-in-clinical-trials