​​​​​​​​​​​​​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 Regulationhttps://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/information-regarding-the-new-clinical-trials-regulationInformation regarding the new Clinical Trials RegulationFrom 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. 536/2014.3000From 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.
Clinical Trials Information System (CTIS)https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/clinical-trials-information-system-ctisClinical Trials Information System (CTIS)Information regarding the CTIS in relation to the implementation of the new Clinical Trial Regulation (Regulation (EU) No 536/2014)2887Information regarding the CTIS in relation to the implementation of the new Clinical Trial Regulation (Regulation (EU) No 536/2014)
Transition period and guidelineshttps://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/transition-period-and-guidelinesTransition period and guidelinesThere will be a transition period of up to three years after the regulation has come into force.3002There will be a transition period of up to three years after the regulation has come into force.
How is NoMA preparing for the new Regulation?https://legemiddelverket.no/english/clinical-trials/new-clinical-trials-regulation/how-is-noma-preparing-for-the-new-regulationHow is NoMA preparing for the new Regulation?Information webinars, user-testing and training - NoMA is preparing for transition to the new regulation in several ways3005Information webinars, user-testing and training - NoMA is preparing for transition to the new regulation in several ways

​Fant du det du lette etter?