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…
