The European Medicines Agency said it is preparing for major clinical trial regulation changes expected under the EU Biotech Act. In comments shared ahead of full adoption later this year, the EMA said it will allocate resources to update CTIS and supporting systems to support faster assessments and reduced administrative burden. The regulator said sponsors and CROs would gain more flexibility to adjust ongoing studies, while CTIS would receive enhanced functionalities to streamline single applications submitted across multiple member states. The EMA positioned the Biotech Act as part of broader EU efforts to boost competitiveness for research and development. The announcement is aimed at operational readiness ahead of proposed timing described by the EMA, with full implementation expected after late-2026 policy processes.