Disappointing update of the EU Commission Clinical Trials Regulation Q&As (EudraLex Vol 10) released today
Pierre Mermet-Bouvier
![Pierre Mermet-Bouvier]()
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
Today, the EU Commission released an updated version (Version 6) of the Clinical Trials Regulation Q&As in EudraLex Vol 10.
A few Updates & new Questions were added, but the highly expected Appendix II (Language requirements for part I documents) and Appendix III (Acceptability of Part II templates in the Member States) are respectively still partial or empty :-(
https://ec.europa.eu/health/system/files/2022-04/regulation5362014_qa_en.pdf
https://ec.europa.eu/health/latest-updates/questions-and-answers-document-regulation-eu-5362014-version-6-april-2022-2022-04-13_en