Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications

News 19/01/2023

On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications and will serve as the single-entry point for submission by sponsors and for regulatory assessment. This follows one year of transition, during which sponsors could choose whether to submit a new clinical trial application in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022.

As the implementation milestone approaches, in an ad-hoc meeting that took place on 18 January 2023 EMA’s Management Board was provided with an update on recent improvements introduced in the system and progress made to prepare for mandatory use.

EMA informed the Board of the latest updates of CTIS and the ongoing collaborative work with Member States to improve the user experience. Since the last meeting of the Board in December, significant progress has been made and now more than 80% of the blocking issues and related workarounds have been resolved, with activities remaining on track to deliver a system with no blocking bugs on core functionalities by 31 January 2023. The Board noted the progress towards further improvement of the system in preparation for the mandatory use and its commitment for the system to be functional for the 31 of January 2023 and in compliance with the relevant CTR provisions from this date.

The Agency briefed the Board on the next steps, including the delivery plan for the end of January 2023 and the system releases planned for the first quarter of 2023. Further enhancements will be made throughout 2023 and EMA will continue to provide weekly reports.

The Management Board welcomed the progress made as well as the enhanced communication and engagement activities involving CTIS users and stakeholders.

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