Sideinnhold
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) |
