The CTIS System becomes the only channel for requests for clinical drug trials
- CTIS will facilitate the coordinated evaluation of clinical trials in the EEA, contributing to the understanding of the benefits and risks of investigational medicinal products
- On January 31, 2023, the first of the three years of transition marked by the European Regulation of Clinical Trials for adaptation to the new system will be fulfilled.
With the new European Regulation of Clinical Trials, in force since January 31, 2022, the European Union (EU) and the European Economic Area (EEA) take another step in the transition process towards a new working method in the field of clinical research with drugs.
This date marks the completion of the first of the three transition years provided by the regulation for the gradual adaptation to its guidelines. One of these mandatory guidelines indicates that, from January 31, 2023, all new applications for clinical trials must be submitted through the Information System CTIS (Clinical Trial Information System).
During the first year of transition, sponsors and regulators of clinical trials could submit their initial applications in accordance with the Clinical Trials Regulation, or according to current national legislation that transposes Directive 2001/20/EC (in the case of Spain , Royal Decree 1090/2015). As of January 31, 2023, the communication of applications through CTIS becomes mandatory.
In the next two years, until January 31, 2025, all ongoing clinical trials that were approved in accordance with the aforementioned directive, will have to adhere to the regulation and must be transferred to CTIS.
CTIS is a database managed by the European Medicines Agency (EMA), whose purpose is to evaluate in a coordinated manner clinical trials in the EEA, which includes the EU countries and Iceland, Liechtenstein and Norway. With a single application, CTIS will allow promoters to apply for the authorization of a new clinical trial in up to 30 countries, optimizing and simplifying the processes.
It is important to note that, from January 31, 2023, also The options for sending test requests through national portals will be disabled.
In order to facilitate the start of this new stage, the Spanish Agency for Medicines and Health Products (AEMPS) makes updated information available to interested parties on its website, specifically in the section on Research with medicines for human use. An explanatory document focused on the aforementioned regulation and on CTIS will also be published shortly, in order to help promoters. For its part, the AEMPS Clinical Trials Area has an inquiry mailbox (aecaem@aemps.es) to whom questions that arise in this regard can be addressed.
On the other hand, the EMA has prepared a Training program, in order to assist sponsors, EEA states and ethics committees in the use of CTIS. In turn, the European Commission has recently published a Fast guide about the new procedure, which will also be useful to promoters in putting these guidelines into practice.
All trials authorized through CTIS will be published both in the European Public Portal for Clinical Trials as in the Spanish Registry of clinical studies (REec) of the AEMPS.