Drug database
Important information for clinical trial applicants on the entry into force of Regulation 536/2014 and how it can be applied in practice
The State Institute for Drug Control informs sponsors, monitors, representatives of contracting organisations and all those working in the field of clinical trials of the deadline for the launch of the EU portal and database, that will be 31 January 2022.
The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.
For more information see the EMA website.
August 2, 2021
Department of Clinical Trials on Pharmaceuticals