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EU Clinical Trial Regulation to Take Effect on 31 January 2022

Author
Allos Rafi
Rafi Allos

Senior Associate

London

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Zhuleku Eda
Eda Zhuleku

Counsel

Munich

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13 August 2021

The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022.

A notice published in the Official Journal of the European Union on 31 July 2021 confirmed the Commission has verified that, following an independent audit, the EU portal and EU database comprising the new Clinical Trials Information System (CTIS) has met the previously published specifications for functionality and is ready to go live six months from the date of the notice. Access to CTIS will enable the Clinical Trials Regulation, which harmonises the submission, assessment and supervision processes for clinical trials throughout the EU, finally to become operational. The Regulation will repeal the existing Clinical Trials Directive and apply directly in all EU Member States and the EEA. It will replace the existing system of different national rules with a harmonised regime across the EU.

The European Medicines Agency is responsible for maintaining CTIS and has published training and support materials on how to use it. These include online training modules, a handbook for clinical trial sponsors, a master trainer programme and training and information events.  

“The CTR forsees a three year transition period to CTIS. Member States will have to work in CTIS immediately from go live once applications are submitted. Sponsors will have one year to begin using CTIS and can decide whether to submit a new clinical trial application under the Clinical Trial Directive or Clinical Trial Regulation until 31 January 2023.” (cf. Peter Arlett)

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