CTIS: a milestone in European clinical research

On January 30, 2025, European clinical research reached a pivotal milestone: the full transition of all clinical trials to the Clinical Trial Information System (CTIS). This marked the complete implementation of the European Clinical Trials Regulation (CTR), a regulatory framework designed to harmonize and modernize the management of clinical trials across the European Union.

The transition from the former Clinical Trials Directive (CTD) to the CTR represents a paradigm shift in how clinical trials are conducted and managed in Europe. Previously, each country followed different procedures and timelines, complicating the execution of multinational trials. Now, with the CTR and CTIS, clinical trial evaluations are harmonized across EU countries, streamlining response times and regulatory requirements. This allows sponsors to submit a single authorization request for all participating countries through a unified portal, the CTIS. Core study documents, such as the protocol and investigational drug information, are jointly assessed by all involved nations.

The CTR has established a unified legal framework for conducting clinical trials

One of its main achievements is the harmonization of Part I documents, which are now standardized across all participating countries, simplifying multinational trials. However, there is still work to be done. Part II documents—such as patient information sheets—remain subject to country-specific requirements. Further harmonization in this area would facilitate even greater efficiency in international clinical research. Additionally, greater transparency under CTR standards, including access to study protocols, could enhance trial design and optimize study execution.

Despite these advances, some regulatory challenges remain

For example, in trials involving genetically modified organisms (GMOs), even though CTIS enables approval across Europe, separate national applications are still required for GMO release. A centralized application process, similar to CTIS, could simplify this step. Another area requiring improvement is the regulation of trials involving both medicinal products and medical devices, as they currently require separate submissions.

Beyond regulatory efficiency, CTIS plays a vital role in strengthening Europe’s position in global clinical research. In recent years, the region has faced growing competition from the United States and Asia. To remain a leader, the EU needed a harmonized system that not only fosters innovation and economic growth but, most importantly, enhances patient well-being and quality of life.

The implementation of CTIS is a significant leap forward—one that will shape a more efficient, competitive, and transparent clinical research ecosystem in Europe, benefiting researchers, industry stakeholders, and, ultimately, patients.

By Lidya Domínguez, director of Clinical Research at Sermes CRO