Clinical Trials Regulation - Version 6.6 of the Q&As

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR).

Compared to the previous Version 6.5 the following Q&s have been revised / added:

Review of point 102 (regarding authorized CTs subject to conditions)
New Q&A 7.51
Review of Q&A 9.4 (relating to informed consent)
Annex II: NL (fields of the application form); SK, EE, LV (patient facing documents)
Annex III: LU contact points for part I and II

Of particular note is the new question 7.51 on radiopharmaceuticals, which deals with documentation on exposure to ionising radiation in clinical trials. The CTR does not address this issue comprehensively and it was previously unclear to what extent corresponding information had to be submitted with the application for approval. The response clarifies what must be submitted and additionally explains what differences the EC sees between radiotherapeutic and radiodiagnostic procedures.

Amongst others, the sponsor is expected to include information on exposure to ionising radiation in the protocol in line with CTR Annex I, section D to allow assessment of the benefits and risks of the clinical trial. The specifics of the information to be included will depend on the situation of exposure (i.e., radiodiagnostic / radiotherapeutic procedures).

More information is available in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.6 available in EudraLex - Volume 10 - Clinical trials guidelines.