On 31st July 2021, the European Commission confirmed the entry into application of the Clinical Trial Regulation (EU) No 536/2014 by the publication of a notice in the Official Journal of the European Union. As set out in the Regulation, this publication starts the six-month countdown to CTIS go-live and confirms the go-live date for CTIS as 31st of January 2022.
The official press release can be found on EMAs website.
Please see the European Commission's publication of a notice in the Official Journal of the European Union.
|Information regarding the new Clinical Trials Regulation||https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/information-regarding-the-new-clinical-trials-regulation||Information regarding the new Clinical Trials Regulation||From the 31st of January 2022, clinical trials conducted in the EU will be regulated under a new regulatory framework, the EU Clinical Trials Regulation no. 536/2014.||3000|
|Clinical Trials Information System (CTIS)||https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/clinical-trials-information-system-ctis||Clinical Trials Information System (CTIS)||Information regarding the CTIS in relation to the implementation of the new Clinical Trial Regulation (Regulation (EU) No 536/2014)||2887||Information regarding the CTIS in relation to the implementation of the new Clinical Trial Regulation (Regulation (EU) No 536/2014)|