EMA: Multi-factor Authentication for CTIS Mandatory by June
From 1 June 2023 multi-factor authentication (MFA) will be introduced for user login to CTIS (Clinical Trials Information System) for both sponsors and Member States. This should significantly increase user account security.
To prepare for MFA, each user will need to be equipped with an additional mobile or work phone. Registration and setup are already available on the EMA's ServiceNow portal. This will also be directly functional for the CTIS system. More information about the activation process can be found here. The CTIS Training Environment does not require any additional authorisation steps. Since the launch of CTIS in January 2022, more than 1000 applications for initial clinical trials have been submitted. More than 400 clinical trials have been approved under the Clinical Trials Regulation (CTR) and made available in the system.
Please note:
On 30 January 2025, all ongoing studies that have been approved according to the "old" Clinical Trials Directive will fall under the now applicable CTR (Clinical Trials Regulation (EU) No. 536/2014). From this date onwards, ongoing trials will also have to be transferred to the CTIS system.
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