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

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.

CRU Hungary performs all new study submissions according to the CTIS. CRU’s Regulatory team is familiar with the CTIS after many successfull submisisons within this new system.