Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan
Pharmaceuticals and Medical Devices Agencies (PMDA) receives the non-clinical safety studies following Good Laboratory Practice (GLP) for the marketing authorization of medical products. Here we analyzed the trends of GLP-compliant non-clinical studies (GLP studies) submitted to PMDA from FY2017 to...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1591433/full |
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| author | Yusuke Oku Hitoshi Someya |
| author_facet | Yusuke Oku Hitoshi Someya |
| author_sort | Yusuke Oku |
| collection | DOAJ |
| description | Pharmaceuticals and Medical Devices Agencies (PMDA) receives the non-clinical safety studies following Good Laboratory Practice (GLP) for the marketing authorization of medical products. Here we analyzed the trends of GLP-compliant non-clinical studies (GLP studies) submitted to PMDA from FY2017 to FY2023. Geographical analysis of the origin of studies revealed that the share of Japanese studies slightly decreased over years, reflecting the drug lag/loss in Japan. This was supported by the analysis of the time from the completion of GLP studies to submissions. Importantly, studies from China and Taiwan were emerging, reflecting the active drug development in China, which is not the adherent to the OECD Mutual Acceptance of Data (MAD). We also discuss the PMDA’s policies on the GLP studies conducted in non-MAD countries. |
| format | Article |
| id | doaj-art-9ed9bebc7a8a4da08a9ad373530b7acd |
| institution | DOAJ |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-9ed9bebc7a8a4da08a9ad373530b7acd2025-08-20T03:16:08ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-07-011610.3389/fphar.2025.15914331591433Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in JapanYusuke OkuHitoshi SomeyaPharmaceuticals and Medical Devices Agencies (PMDA) receives the non-clinical safety studies following Good Laboratory Practice (GLP) for the marketing authorization of medical products. Here we analyzed the trends of GLP-compliant non-clinical studies (GLP studies) submitted to PMDA from FY2017 to FY2023. Geographical analysis of the origin of studies revealed that the share of Japanese studies slightly decreased over years, reflecting the drug lag/loss in Japan. This was supported by the analysis of the time from the completion of GLP studies to submissions. Importantly, studies from China and Taiwan were emerging, reflecting the active drug development in China, which is not the adherent to the OECD Mutual Acceptance of Data (MAD). We also discuss the PMDA’s policies on the GLP studies conducted in non-MAD countries.https://www.frontiersin.org/articles/10.3389/fphar.2025.1591433/fullgood laboratory practice (GLP)non-clinical safety studypharmaceuticalsregenerative medical productsOrganisation for Economic Cooperation and Development (OECD)mutual acceptance of data (MAD) |
| spellingShingle | Yusuke Oku Hitoshi Someya Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan Frontiers in Pharmacology good laboratory practice (GLP) non-clinical safety study pharmaceuticals regenerative medical products Organisation for Economic Cooperation and Development (OECD) mutual acceptance of data (MAD) |
| title | Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan |
| title_full | Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan |
| title_fullStr | Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan |
| title_full_unstemmed | Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan |
| title_short | Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan |
| title_sort | trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in japan |
| topic | good laboratory practice (GLP) non-clinical safety study pharmaceuticals regenerative medical products Organisation for Economic Cooperation and Development (OECD) mutual acceptance of data (MAD) |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1591433/full |
| work_keys_str_mv | AT yusukeoku trendsingoodlaboratorypracticestudiessubmittedforthemarketingauthorizationofpharmaceuticalsinjapan AT hitoshisomeya trendsingoodlaboratorypracticestudiessubmittedforthemarketingauthorizationofpharmaceuticalsinjapan |