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As of 31 January 2023, all new initial clinical 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.
I want to start a new clinical trial in the EU/EEA. Please take me to the CTIS portal.
I want to add a new EU/EEA-country to my trial. This can be done after the EudraCT trial is transitioned to CTIS: please show me more information on transitional trials.
I want to create a new clinical trial application (CTA) XML file because I want to perform an amendment to a CTA XML file of a trial for which the initial application was submitted to the same National Competent Authority before 31 January 2023, but I lost the original CTA XML file (and therefore the CTA XML file cannot be "loaded" but I need to create it again).
