Summary
The European Medicines Agency plans to begin work on a modernised Clinical Trials Information System platform in early 2027. The upgrade is intended to support changes proposed in the EU Biotech Act, which remains under discussion.
The European Medicines Agency (EMA) plans to begin work in early 2027 on a new, modernised platform for the Clinical Trials Information System (CTIS). The system is intended to support changes proposed in the European Commission’s Biotech Act, including faster trial assessments and more flexible handling of changes to ongoing studies. The proposed legislation is still under discussion in the European Council and Parliament.
The plans were outlined in highlights from the EMA Management Board’s September 2026 meeting, published on 1 October. The Board said preparing CTIS for the proposed rules will require immediate investment in the existing platform as well as development of a new one.
The system supporting clinical-trial applications across the EU
CTIS launched in 2022 and operates as a single system for clinical trials across EU Member States. It supports the authorisation and management of trials under the EU Clinical Trials Regulation. EMA reported that CTIS has supported more than 14,000 clinical trials since launch and receives more than 200 new trial applications each month.
The agency says the system also supports cross-border collaboration and transparency in medicines development. A modernisation initiative began in 2025, with the aim of preparing CTIS for a growing volume of submissions.
Proposed changes would affect much of CTIS
The legislative proposal would change authorisation and supervision of clinical trials in ways that affect approximately 70% of CTIS’s current functionality, according to EMA. The proposed capabilities include faster assessment, greater flexibility for major changes to ongoing trials, stronger collaboration between Member States and more proportionate, risk-based authorisation procedures. The proposal also includes common medicinal product dossiers and simpler assessment of studies that combine medicines with medical devices or in vitro diagnostics.
These are proposed changes, not features already available in CTIS. EMA expects the system to support key Biotech Act functions as soon as possible after the legislation is adopted. The Commission’s legislative proposal was adopted in December 2025 and is now being considered by the Council and Parliament. Based on the ambitious timetable for that process, the first changes to the clinical-trial rules could come into force in early 2028.
The Board stressed that preparation should advance ahead of adoption, particularly for features such as accelerated assessment timelines. EMA plans to deliver the functionality foreseen by the Biotech Act through the new CTIS platform, with development work due to start in early 2027. A detailed roadmap, including the resources required, is scheduled for presentation to the Board in December 2026.