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EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
The European Commission (EC) has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
Notification of the entry into the Clinical Trial Regulation was published in a notice in the Official Journal of the European Union, confirming that the clinical trial European Union (EU) Portal and Database have reached full functionality.As reported in an Aug. 2, 2021 press release from the European Medicines Agency (EMA), both the application of the regulation and the go-live of the CTIS are set to take place six months after the publication of the notice.
CTIS will become the single point of entry for any clinical trial application submission, authorization, and supervision within the EU and the European Economic Area (EEA). With the new system, clinical trial sponsors will be able to apply for clinical trial authorization in up to 30 EEA countries with a single application, EMA specified in the press release.
Additionally, the CTIS, in conjunction with other EMA IT tools, will support the coordinated assessment of clinical trial safety reporting and will facilitate recruitment of trial participants by allowing sponsors and researchers to expand trials to other EEA countries.
It is hoped that the CTIS will foster better transparency and collaboration across borders within the EU and EEA countries. The CTIS will comprise a public website, which will host detailed information on clinical trials and the outcomes of the clinical trials that are conducted in the EU.
More information on the regulation and new system can be found on EMA’s website.