Clinical trials for medicines: Clinical Trials Regulations transitional arrangements

Latest change: Clarified: It is not necessary to modify labels that have already been approved to replace the term “patient”, “subject” or similar with “participant”, although use of the term “participant” is strongly encouraged for labels approved after 28 April 2026. The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.