The one-year transition period that followed the entry into force of the new Clinical Trials Regulation (Regulation EU/536/2014, also known as CTR) will end on 31 January. During this transitional period, clinical trial sponsors had the option of submitting an application for a new clinical trial through the national submission procedures under the old regulation (Directive 2001/20/EC) or submitting their application through the Clinical Trials Information System (CTIS) under the new regulation.
From 31 January 2023, the use of CTIS will become mandatory for the submission of new clinical trial applications. The CTIS will serve as a single entry point for clinical trial submissions and regulatory assessments.
The European Medicines Agency (EMA) management board – at a meeting dedicated to this transition on 18 January 2023 – was informed of the latest improvements that had been introduced in the system and the progress that has been made in preparing for the mandatory use of CTIS.
The EMA informed the Steering Board that since the last management board meeting on 14–15 December 2022 (see EUROPE 13087/11), more than 80% of the blocking issues and related workarounds have been resolved.
The EMA is confident that it will have a technically operational system, free from blocking issues related to core functionalities, by the deadline of 31 January 2023.
Work is continuing in dialogue with Member States.
The EMA states that further improvements will be made to the system in 2023. This progress will be reported weekly by the EMA. (Original version in French by Émilie Vanderhulst)