Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products
Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decisio...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/20523211.2025.2523935 |
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| _version_ | 1849421383658897408 |
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| author | Chieko Ishiguro Yasutomo Teshima Harumasa Nakamura |
| author_facet | Chieko Ishiguro Yasutomo Teshima Harumasa Nakamura |
| author_sort | Chieko Ishiguro |
| collection | DOAJ |
| description | Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decision-making, especially focusing on the use of disease registries. In this brief article, we outline regulatory initiatives, summarise the current status of registry utilisation in Japanese regulatory settings, and offer points to consider and perspectives on registry utilisation for stakeholder collaboration. |
| format | Article |
| id | doaj-art-ddc7813d33f84e98a1aa8b63c7c8d8ee |
| institution | Kabale University |
| issn | 2052-3211 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj-art-ddc7813d33f84e98a1aa8b63c7c8d8ee2025-08-20T03:31:28ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112025-12-0118110.1080/20523211.2025.2523935Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine productsChieko Ishiguro0Yasutomo Teshima1Harumasa Nakamura2Laboratory of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, Japan Institute for Health Security, Tokyo, JapanPharmacovigilance and Post Marketing Surveillance, Aculys Pharma Inc., Tokyo, JapanDepartment of Clinical Research Support, Clinical Research & Education Promotion Division, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, JapanConsiderable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products. In Japan, regulatory initiatives have been implemented to promote the utilisation of real-world data and evidence for regulatory decision-making, especially focusing on the use of disease registries. In this brief article, we outline regulatory initiatives, summarise the current status of registry utilisation in Japanese regulatory settings, and offer points to consider and perspectives on registry utilisation for stakeholder collaboration.https://www.tandfonline.com/doi/10.1080/20523211.2025.2523935Real-world datareal-world evidenceregistryregulatoryJapan |
| spellingShingle | Chieko Ishiguro Yasutomo Teshima Harumasa Nakamura Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products Journal of Pharmaceutical Policy and Practice Real-world data real-world evidence registry regulatory Japan |
| title | Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products |
| title_full | Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products |
| title_fullStr | Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products |
| title_full_unstemmed | Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products |
| title_short | Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products |
| title_sort | current and future perspective of registry utilisation for regulatory settings in japan pharmaceuticals medical devices and regenerative medicine products |
| topic | Real-world data real-world evidence registry regulatory Japan |
| url | https://www.tandfonline.com/doi/10.1080/20523211.2025.2523935 |
| work_keys_str_mv | AT chiekoishiguro currentandfutureperspectiveofregistryutilisationforregulatorysettingsinjapanpharmaceuticalsmedicaldevicesandregenerativemedicineproducts AT yasutomoteshima currentandfutureperspectiveofregistryutilisationforregulatorysettingsinjapanpharmaceuticalsmedicaldevicesandregenerativemedicineproducts AT harumasanakamura currentandfutureperspectiveofregistryutilisationforregulatorysettingsinjapanpharmaceuticalsmedicaldevicesandregenerativemedicineproducts |