Clinical Trials Regulation - Version 6.3 of the Q&As

The European Commission (EC) published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022. 

Changes in Version 6.3

Compared to the previous Version 6.2 the following has been changed:

  • Several amended and two additional paragraphs (485 and 499): The sponsor needs to declare in the cover letter that all documents which need approval and are transitioned to the CTR, including the ones that will be transitioned, have been approved by all the MSCs prior transition. The two introduced paragraphs are relating to the question: "What are the conditions for switching the regulatory framework of a trial from the Directive to the CTR?

  • Amended question 1.19: Which principles of Good Laboratory Practice (GLP) need to be taken into account for the authorisation of clinical trials?
    Non-clinical information submitted in an application dossier shall be based on data derived from studies complying with Union law on the principles of GLP as laid out in Directive 2004/10/EC on non-clinical safety studies. In addition, sponsors should include a statement confirming the GLP status of the studies or equivalent standards (i.e. principles of GLP recognised by other countries) within the IMPD (Investigational Medicinal Product Dossier).

  • Review of Annex II: Language requirements for part I documents 

  • Creation of Annex III: Part II documentation - where sponsors can find national requirements.
    The Annex lists websites where sponsors can find important information to submit high quality Part II documents as part of their clinical trial applications (CTAs) together with e-mail addresses for enquiries related to Part I and  Part II CTAs. However, it is noted that that the national competent authorities or the contact points indicated in the Annex may not reply to enquiries for which an answer is already available either in the CTR or in the corresponding Q&A document or in national Q&A documents.

More information can be found in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.3 in EudraLex - Volume 10 - Clinical trials guidelines.

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