The European Medicines Agency said it is preparing for “major” Clinical Trial Regulation changes tied to the incoming EU Biotech Act, aiming to reduce sponsor administrative burden while speeding assessments. EMA said its management board will allocate resources to update internal systems before the new rules take effect later this year. The changes include greater flexibility for sponsors and CROs to adjust ongoing studies and enhancements to CTIS, the clinical trials information platform. EMA positioned the Biotech Act as part of the broader ACT EU initiative, building on measures already implemented to streamline submissions across EU member states.