The European Medicines Agency said the EU Clinical Trials Information System (CTIS) will need a major rebuild to support changes proposed under the EU Biotech Act, affecting roughly 70% of current CTIS functionality. The agency cited the need for faster assessment timelines and greater flexibility for modifying ongoing studies, as well as improved cross-member-state collaboration. EMA said development of a “new modern CTIS platform” will start in early 2027, with a detailed redevelopment plan due in December. If adopted, changes tied to clinical trial authorisation and supervision could arrive as early as 2028. For biotech sponsors, the immediate impact is planning uncertainty around data submission workflows and study modification processes—especially for programs that rely on rapid protocol updates during enrollment and dose-optimization periods.