Clinical Trials Regulation - Version 6.9 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) has published an updated Version 6.9 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR).

The following Q&s have been revised / added:

Revised Q&As 2.9 (regarding the publication of the assessment report on part I and II) and 6.5 (on the CTIS publication rules) in line with the revised CTIS transparency rules.
Revised Q&A 3.13 on the change of the principal investigator
Revised Q&A 6.1 (on endpoints to be summarized in the summary of results) including reference to paediatric clinical trial results
New Q&A 6.6 on intermediate data analysis
Annex II (Language requirements for part I documents): Footnote 2 (patient facing documents) also applies to Estonia (to be submitted at least in the official national language(s) of the region(s) where the trial is conducted. EN is optional)
Annex III (Part II documentation - where sponsors can find national requirements): Hungary: New Email address for enquiries related to Part I clinical trial applications; Finland: new national websites; Romania: New Email address for enquiries related to Part II clinical trial applications
Annex IV (Classification of changes to ongoing clinical trials): Extension of validity decision as substantial modification for part I+II or part II only
Annex V (Changes to source country): Deletion of Summary of product characteristics (SmPC) requirement for authorized AxMPs

More information is available in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.9 available in EudraLex - Volume 10 - Clinical trials guidelines.