CTIS - READY OR NOT, HERE IT COMES

CTIS is the online system for the regulatory submission, authorization and supervision of clinical trials in the EU and the European Economic Area. It is a single-entry point for all clinical trial data. As of 31st January next year, the use of the CTIS will be mandatory for all initial submissions and with just over 2 months to go ‘live’ the question lies in are you truly ready?

READY OR NOT, HERE IT COMES

Q&A with Zuzana Baťová, Head of Regulatory Department, SanaClis

What is the Exact Transition Period?

The rules are as follows: Until 30 January 2023, clinical trial sponsors may use CTIS to apply to run a clinical trial under the Clinical Trials Regulation or may choose to apply to run a trial under the Clinical Trials Directive. From 31 January 2023, clinical trial sponsors will need to use CTIS to apply to start a new clinical trial in the EU/EEA. From 31 January 2025, any trials approved under the Clinical Trials Directive that continue running will need to comply with the Clinical Trials Regulation and their sponsors must have recorded information on them in CTIS.

Is it Possible to Submit a Mixed Application - a Whole Application (Part I and II) to Some Member States Concerned at the Same Time as an Application Limited to Part I Only to Other Member States Concerned?

Yes, it is possible. Based on the Q§A published by the European Commission, the Member States in which the sponsor submitted the whole application would assess the whole dossier, and after the positive decisions by these Member States concerned are issued, a clinical trial can start in those concerned Member States. 

What Different Roles are There in CTIS?

In the sponsor workspace there are up to 18 roles. One user can have more than one role. SanaClis has high- level CTIS administrator role, so we are able to manage different roles and permissions upon the need of the sponsor. The business role is divided into a viewer, preparer and submitter role. 

How Can SanaClis Support Sponsors in this Major Shift?

Sponsors coming from industry or academia will need to build new workflows and new processes in order to manage a clinical trial’s lifecycle. It is of utmost importance to ensure that the CRO they partner with has done the same.  The submission dossier is divided into two parts. Part I contains scientific documentations and Part II contains national and patient facing documentation that are typically assessed by Ethic Committee. We are ready to prepare, review and upload documentation that must be included in Part I as well as Part II.

We are prepared to fully support our clients during this transition, allowing them to significantly reduce time and cost, while standardizing their processes within EU Member States and the EEA.

 

 

In her stellar career, most notably, Zuzana Batova was the Executive Director of the National Competent Authority in Slovakia (State Institute for Drug Control). For over 5 years, Zuzana was responsible for the final decision making in the field of human pharmacy such as granting marketing authorization, authorization of clinical trials and drug recall. She also represented the agency on national and international level (V4 Presidency, SK Presidency and EMA Management Board). Prior to that, Zuzana was heading the Drug Registration Department at the State Institute for Drug Control and took charge of the activities associated with the marketing authorization of human medical products, ensuring that approved medicines meet appropriate standards of quality, safety and efficacy coming from the ICH, European Medicines Agency and World Health Organization guidelines.

For more information on regulatory guidance, reach out to our dedicated team: info@sanaclis.com