January 2022: EU CTIS is Live and Functioning

The EU Member States and EEA countries (EU/EEA), the European Commission, and European Medicines Agency (EMA) collaboratively launched the European Union Clinical Trials Information System (EU CTIS) on January 31, 2022. As per the Clinical Trials Regulation launched on the same day, EU/EEA countries will now assess and oversee Clinical trials using CTIS.  EMA also launched a new clinical trials website that is now accessible with secure workspaces and a public searchable database.

The secure workspaces include ‘CTIS for sponsors’ and ‘CTIS for authorities’. It is mentioned as of now there is limited information on individual clinical trials in the database of the website. It will eventually contain more information as clinical trial sponsors and EU/EEA regulators use it to initiate and oversee clinical trials in the EU and EEA.  The website also provides links for training and support materials over the website.