IMPORTANT NOTICE FOR INVESTIGATORS WHOSE PROJECT PROPOSAL CORRESPONDS TO A CLINICAL EVALUATION MEDICINAL PRODUCTS

On 31 January 2022, the Clinical Trials Regulation (Regulation (EU) No. 536/2014) entered into force, harmonising submission, evaluation and oversight procedures for clinical evaluation trials in the EU through the Clinical evaluation Information System (CTIS).

The Clinical Trials Regulation provides for a three-year period for the transition to CTIS.

From 31 January 2022 to 31 January 2023, sponsors of clinical evaluation may choose whether to submit their clinical evaluation applications under the Clinical Trials Directive (EC) No 2001/20/EC through national application procedures or under the Clinical Trials Regulation through the CTIS. (I.e. only until 31.1.2023 can an application for a notified clinical evaluation be submitted directly to the CRL and any ethics committee (if there is more than one centre per ethics committee for multicentre clinical evaluation, if there is only one centre per clinical evaluation per local = local ethics committee).

As of 31 January 2023, all new applications for clinical evaluation in the EU and EEA can only be submitted through the CTIS (ClinicalTrialsInformationSystem), i.e. through the EU portal in accordance with the Clinical Trials Regulation. There will be no other option to submit a request for a clinical evaluation authorisation. More information is available on the SÚKL website.

As of 31 January 2025, all clinical evaluation will be authorised and run exclusively under Regulation 536/2014. Clinical evaluation that are still ongoing and have been authorised under the Clinical Trials Directive must be transferred to the Clinical Trials Regulation and the CTIS.

Based on the information from SÚKL, we draw your attention to this fact in advance, as the assessment of the application submitted via CTIS takes the shortest possible time, when there are no comments and all the submitted documentation is in order, 14 days. We would also like to draw your attention to the fact that clinical assessments submitted via CTIS are subject to the opinion of SÚKL and the Ethics Committee of SÚKL, no other ethics committee can be requested. The scope of documentation required for the review of the application by the Ethics Committee is specified in the SÚKL KLH-CTIS-01 instruction.