The European Commission has published Version 7.4 of the Questions & Answers on Clinical Trials Regulation (EU) No 536/2014 (CTR), dated October 2026.
This document sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on clinical trials.
The revised document provides further clarification on the submission of clinical trial results through the Clinical Trials Information System (CTIS), alongside updated Member State language requirements for investigational medicinal product (IMP) labelling.
CLINICAL TRIALS REGULATION (EU) NO 536/2014 QUESTIONS & ANSWERS
VERSION 7.4