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Article History

Accepted: 24 March 2026

First Online: 4 May 2026

Declarations

:

: Olaf Witt serves as advisory board member for Novartis, Ipsen, BMS Janssen and receives research grant support from Day One Biopharmaceuticals and BioMed Valley Discoveries. Cornelis van Tilburg reports serving on advisory boards for Alexion, Bayer, Novartis, and Roche, receiving travel support from Eli Lilly, lecture honoraria from Ipsen, and received research grants from BioMed Valley Discoveries and Day One Biopharmaceuticals. All activities were outside the submitted work. Laura Fankhauser, Franca Ligas, Giovanni Lesa, Anette Solli Karlsen, Marianne Lunzer, Monique Al, Sabine Scherer, Sylvie Benchetrit, Claudia Riedel, Annette Kopp-Schneider, Ruth Witt, and Dominik Karres declare no competing interests.

: The data analysed in this study were accessed through special administrator privileges in the Clinical Trial Information System (CTIS) and contain confidential regulatory information. While information about approved clinical trials are publicly available via the EMA website ( ), detailed assessment data used in this analysis are not publicly accessible due to confidentiality requirements between the regulatory authorities and the sponsor of the trial.

: Ethics approval was not required as this study involved retrospective analysis of anonymised regulatory assessment data without access to individual patient information. The analysis was conducted within the framework of an official EMA fellowship with appropriate data access permissions.

: Not applicable.

: Not applicable.

: Not applicable.

: Laura Fankhauser, Ruth Witt, Olaf Witt, Dominik Karres and Cornelis van Tilburg conceptualised the study. Laura Fankhauser conducted all analyses of Clinical Trial Applications in CTIS, developed and implemented the analytical methodology, created all figures and visualisations, and wrote the first draft of the manuscript. Franca Ligas, Giovanni Lesa and Dominik Karres contributed to data interpretation from the EMA perspective. Anette Solli Karlsen, Marianne Lunzer, Monique Al, Sabine Scherer, Claudia Riedel and Sylvie Benchetrit provided national regulatory expertise and contributed to data interpretation from a national competent authority perspective. Annette Kopp-Schneider performed the statistical analyses. Cornelis van Tilburg and Dominik Karres supervised the study and critically reviewed and edited all versions of the manuscript. All authors reviewed and approved the final version of the manuscript and had full access to all the data in the study. Laura Fankhauser and Cornelis van Tilburg verified the underlying data.

: The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.