ArticleClinical pharmacology and therapeutics2025
Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.
Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Advanced therapy medicinal products in Saudi Arabia: Regulation and development.Regenerative therapy · 2026Review
- Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union.Pharmaceuticals (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
New drug applications (NDAs) in Japan are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA). Those that pass the review are subsequently subject to deliberation by the Ministry of Health, Labour and Welfare Pharmaceutical Affairs and Food Sanitation Councils (MHLW-PAFSC), and the MHLW legislatively grants approval based on its positive opinions. However, little is known regarding the relationship between the PMDA review and the MHLW decision. We retrospectively assessed the MHLW decision of NDAs that passed the PMDA review at the initial MHLW-PAFSC deliberation from 2002 to 2022. The reasoning behind a non-supportive opinion from the MHLW-PAFSC and the sponsor's actions to overcome unresolved issues were also documented. A total of 2,117 of 2,153 (98.3%) NDAs that passed the PMDA review were approved at the initial MHLW-PAFSC deliberation with a positive opinion. The remaining 36 applications were not approved at the initial deliberation and subjected to continued deliberation because of a non-supportive opinion from the councils, although 29 were finally approved through revision of the application document (24 applications), re-analysis of the data (1 application), or additional clinical trials (4 applications). Seven applications have not been approved, of which one was refused, four were withdrawn, and two were unknown. The MHLW approves NDAs that passed the PMDA review at the initial deliberation at a high rate, suggesting that NDAs only suitable for approval passed the review and reached the MHLW-PAFSC deliberation. Only a few NDAs were not approved at the initial deliberation; however, most of them were finally approved.
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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 OpenQuestion graph.