The European Medicines Agency (EMA) said it is preparing for major Clinical Trials Regulation updates tied to the incoming EU Biotech Act, including system changes to the Clinical Trials Information System (CTIS). EMA framed the shift as part of an effort to speed assessments, reduce administrative burden, and improve patient access to innovative therapies. EMA also said the Biotech Act would modify how ongoing studies can be adjusted, giving sponsors and CROs more flexibility once the legislation takes effect later this year. The regulator noted that the European Commission proposed the Biotech Act in December 2025 and solicited feedback before adoption. The agency added that it will allocate resources to update systems ahead of the effective date and enhance CTIS functionalities to support streamlined clinical trial applications under the single-submission model.