ArticleTherapeutic innovation & regulatory science2025
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Evaluation of Ease of Use for Pediatric Medications Requiring Decapsulation, Dissolution, or Partial Dosing: A Questionnaire-Based Study in Japan.Therapeutic innovation & regulatory science · 2026Article
- Evaluation of Characteristics and Ethnic Sensitivity for FDA-Approved Drugs with Racial and Ethnic Differences in Pharmacokinetics, Safety, and Efficacy.Journal of clinical pharmacology · 2025Article
- New Horizon in Clinical Development Strategy in Japan Based on New Guideline on Japanese Phase 1 Studies Prior to Multi-Regional Clinical Trials.Clinical and translational science · 2025Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe lack of label information for the pediatric population has been a global issue, leading to the introduction of several countermeasures by major health authorities. Despite various efforts by Japanese health authorities, some drugs are approved only for adults in Japan, while the United States (US) label includes information on pediatric usage for the same drugs. This suggests a potential for pediatric-specific drug loss in Japan, where overall drug loss has recently become a major concern.
methodsIn this study, we compared the pediatric usage status between Japan and the US, focusing on the indications approved in both countries.
resultsOf the 404 indications, 70 (17.3%) and 102 (25.2%) included pediatric usage in Japan and the US, respectively. The proportion of indications, including pediatric usage, was significantly higher in the US than in Japan (χ
conclusionsOur results suggest that there was pediatric-specific drug loss in Japan compared to that in the US. The multivariate analysis demonstrated that US-first development and non-simultaneous development had a negative impact on the inclusion of pediatric usage in Japan; however, pediatric assessment request was not a significant factor. Further frameworks to promote pediatric drug development should be introduced in Japan to address pediatric-specific drug loss issues.
Indexed as
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39441417What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.