EMA is introducing Multi-Factor Authentication (MFA) for the Clinical Trial Information System (CTIS) from 01 June 2023.

30 May 2023

Multi-factor (MFA) authentication for user logins to Clinical Trial Information Systems (CTIS), for both Sponsor and Member State workspaces, will be launched on 1 June 2023. In preparation for the introduction of MFA, it is recommended that each user is equipped with a mobile or an office phone that can be used for second factor authentication. The CTIS is the EU-portal for all applications for clinical trials with investigational medicinal products on humans under the EU Clinical Trials Regulation. You can read more about CTIS on the Danish Medicines Agencys' webpage for the Clinical Trials Regulation

Users can already log into the EMA ServiceNow portal to set up their MFA for EMA systems, which will work also for CTIS once deployed and activated. Further instructions on setting up the MFA for EMA systems are available here.

Authentication can be done either using the Microsoft Autheticator app, via SMS or via a phone call (which is the standard setting). If you already have MFA active, you can change your preferences in the ServiceNow portal. The Danish Medicines Agency cannot provide support for access to EMA systems and refer to the ServiceNow portal for help.

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