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Article History

Accepted: 5 October 2025

First Online: 1 November 2025

Declarations

:

: The authors declare that they have no financial or non-financial competing interests, including personal, professional, or institutional relationships, that could be perceived as influencing the work reported in this manuscript.

: Not applicable.

: Not applicable.

: Not applicable.

: All data used in this study were obtained from publicly available regulatory documents issued by the PMDA and FDA. While summary findings are presented in the manuscript, detailed drug-level data including structural classification, regulatory judgments (PMDA and FDA), and reproductive toxicity findings are provided in Supplementary Table 1 (see ESM), enabling independent verification of the study results. The analysis can be independently verified by consulting the same public regulatory sources.

: Not applicable.

: HK contributed substantially to the conception and design of the study, performed the research, and analyzed the data. KM contributed to the drafting and critical revision of the manuscript, verified the coding results for classification consistency, and also participated in data analysis. Both authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring its accuracy and integrity.