Latest Version of Q&As on Clinical Trials Regulation (V6.4) Released by EU Commission

On February 17, 2023 the latest version of the Q&As on the Clinical Trials Regulation has been released in EudraLex Volume 10 by the EU Commission. The updated version, which is now referred to as Version 6.4, is now available.

One of the notable updates to the Q&As on the Clinical Trials Regulation pertains to Additional Q&A (2.15). This change mainly addresses situations where the sponsor of a clinical trial is not the product owner of the investigational medicinal product (IMPD) and, therefore, is not authorized to access the quality IMPD.

For your reference, the link can be found here: regulation5362014_qa_en.pdf (