The European Medicines Agency signaled major changes to the Clinical Trials Information System to meet proposed Biotech Act requirements. In a plan outlined by the agency, CTIS would need “immediate investment” and substantial redevelopment to support accelerated assessment timelines and greater flexibility for modifying ongoing trials. EMA estimates the proposed changes would impact about 70% of current CTIS functionality. The agency plans to begin development of a new modern CTIS platform in early 2027, with a detailed redevelopment plan due to the EMA management board in December. For biotech sponsors and CROs operating multi-country studies, the upgrade direction increases the probability of workflow changes for trial setup, amendments, and cross-member-state collaboration.