As of 31 January 2023, all new trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through CTIS, including the addition of EU/EEA countries to EudraCT trials.
This page is only available for the loading and amending of a EudraCT Clinical Trial Application (CTA) XML file that was submitted in a certain EU/EEA country before 31 January 2023.
In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to be transitioned to CTIS first: please refer to Clinical Trials Regulation Q&A section 11 for more information.
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