A Clinical Trial Authorization (CTA) is a regulatory submission made by a sponsor to a national competent authority — in coordination with the European Medicines Agency (EMA) — seeking authorization to initiate clinical trials of an investigational drug, biologic, or gene therapy product in human subjects within the European Union. A CTA includes preclinical data, CMC information, clinical trial protocols, and investigator information, and must demonstrate that the product is sufficiently safe and scientifically justified to be tested in humans.
