The European Medicines Agency (EMA) said it is preparing for major Clinical Trials Regulation updates tied to the upcoming EU Biotech Act. EMA management board will allocate resources to update systems in advance of the law taking full effect later this year. EMA described changes aimed at speeding assessments and reducing sponsor administrative burden, alongside greater flexibility to adjust ongoing studies. The regulator also flagged enhancements to CTIS, the Clinical Trials Information System used to submit trial information under the EU’s single-entry model. Separately, the EMA spokesperson linked the Biotech Act’s intent to initiatives under the ACT EU package, including a trial map launched to support sponsors navigating multi-country submissions.