Approval Process for Clinical Trials in Europe

The image shows a flowchart for the approval process for clinical trials (Genehmigungsverfahren für Klinische Prüfungen nach CTR). Here\'s a breakdown of the key steps: Sponsor submits application to all EU states via CTIS: Starting point where the sponsor submits the clinical trial application. CTIS processes the application: Central system used for submission and coordination. National authority (BfArM/PEI) and ethics committee review: The responsible bodies review the application. Decision deadline of 60 days for authorities: Authorities must provide a decision within 60 days. Clock-Stop: The clock is paused while the sponsor addresses questions from authorities. Questions to Sponsor: Questions are directed to the sponsor if required.