The European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) has gone live as of January 31st.
CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the European Union. The Clinical Trials Regulation and CTIS will strengthen clinical trials in the EU, ensuring better outcomes for patients and supporting the attractiveness of the European Union as a location for clinical research.
Sponsors can visit the public Clinical Trials website at https://euclinicaltrials.eu/home. The “CTIS for sponsors” page provides key information and links for sponsor users.
Patients, healthcare professionals and the general public can also access the public Clinical Trials website. When clinical trial applications have been submitted through CTIS and authorised by Member States,they will be openly accessible via the “Search clinical trials page”. The public searchable database will gradually contain more information as sponsors and Member States use it to initiate and oversee clinical trials.