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CTIS, Clinical Trial Information System

CTIS, short for “Clinical Trials Information System”, is a platform operated by the EMA, the European Medicines Agency. Clinical trials are submitted on this platform throughout the entire life cycle by Sponsors and CROs and then assessed and supervised by EU Member States, EEA countries and the European Commission. Since January 31, 2023, all initial applications for clinical trials within the EU must be submitted via CTIS.

CTIS comprises three components:

1. a secure workspace used by clinical trial sponsors and the organizations working with them (e.g., CROs),

2. another secure workspace used by the authorities of the EU Member States and EEA countries as well as the European Commission,

3. and a public website for citizens, containing detailed information on clinical trials that have been applied for and approved in CTIS.