The EMA said it is preparing for major Clinical Trial Regulation changes tied to the proposed EU Biotech Act expected to move forward this year. The agency said it will allocate resources to update internal systems, including the Clinical Trials Information System (CTIS), before the Biotech Act takes effect. EMA described the Biotech Act as aiming to speed assessments and reduce sponsor administrative burden, while also giving sponsors and CROs more flexibility to adjust ongoing studies. The agency also indicated CTIS will get enhanced functionalities to support streamlined submissions across multiple member states. For biotech sponsors, the near-term focus is on whether the regulatory pathway adjustments reduce time-to-start and how change-management flexibility could influence protocol amendments and trial continuity within the EU.