​​​​​​​​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 Training Program for the Clinical Trials Information System (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?3005

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