The European Medicines Agency said the Clinical Trials Information System (CTIS) will need a major rebuild to accommodate the proposed EU Biotech Act. The agency cited that the potential changes to authorization and supervision affect about 70% of current CTIS functionality, including demands for faster assessment timelines and greater flexibility for modifications to ongoing studies. EMA said work on a new modern CTIS platform is planned to begin in early 2027, with a detailed redevelopment plan due in December. If adopted on the Biotech Act timeline, the first changes to clinical trial regulation could come into force in early 2028. For biotech sponsors, the announcement signals procedural and systems updates that may affect trial reporting workflows, change management, and cross-member state collaboration. Early planning for submission and data exchange processes will likely become more important as the platform shifts.