The Clinical Trials Information System (CTIS) has been officially designated as a primary registry by the World Health Organization (WHO), marking a significant advancement in global clinical research transparency and data sharing.
This new status confirms that CTIS meets WHO's rigorous criteria for data quality, accessibility, and technical capacity, enabling it to serve as a trusted source of clinical trial information within the International Clinical Trials Registry Platform (ICTRP).
CTIS has been a registered data provider to WHO since May 2023. With its new designation, data from clinical trials published in CTIS—dating back to its launch on January 31, 2022—are now searchable via the ICTRP portal. This step enhances access for researchers, regulators, and healthcare professionals worldwide.
The move also aligns CTIS with standards set by the International Committee of Medical Journal Editors (ICMJE), a key requirement for trials to be considered for publication in top-tier medical journals.
CTIS supports the conduct of clinical trials for human medicines in the European Union (EU) and European Economic Area (EEA). It includes a public-facing searchable database and an interactive trial map to help patients and healthcare professionals locate nearby recruiting trials.
The system, maintained by the European Medicines Agency (EMA) and overseen by the European Commission, replaces the EU Clinical Trials Register, which had held WHO primary registry status since 2011.
The designation underscores CTIS’s growing role in promoting trust, transparency, and accessibility in clinical research across Europe and beyond.
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