EU Regulation 536/2014

6 months after the publication of REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

in the Official Journal of the European Union, the clinical trial authorization procedure will be changed. This date is expected to be the 31^st of January 2022. Detailed information will be published on our website after the publication, and training is planned to be organized on the new Clinical Trials Information System (CTIS) and important authorization issues.

We would like to inform you that important information and educational materials on the new legislation and CTIS can be found on the website of the European Commission and the EMA:

https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1

https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme#introduction-to-ctis-section