2025.10.17
Japan’s Early Consideration on Handling of Japanese Data for Biosimilar Comparability
Introduction to Regulatory Perspective According to the PMDA’s provisional translation released on September 1 […]
2025.09.30
Key Takeaways from the PMDA Symposium on Japanese Phase I Trials Before MRCT Participation
Introduction On August 4, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) hosted a public symposiu […]
2025.09.17
PMDA Symposium 2025: Key Takeaways for Pediatric Drug Development
IntroductionOn August 27, 2025, the PMDA hosted a symposium titled “Toward Enhanced Pediatric Pharmacotherapy […]
2025.08.26
Expediting Drug Development in Japan: Key PMDA Initiatives
IntroductionPMDA has reduced median new drug review times from over 600 days in 2005 to 333 days in 2023, matc […]
2025.04.30
Japan Identifies 14 High-Priority Drugs in Effort to Resolve “Drug Loss” Issue
Introduction to the Drug Loss IssueAccording to news (厚労省 ドラッグ・ロス86品目で「医療上必要性特に高い」医薬品14品目 類薬あり至急の開発不要品目も | ニュー […]
2025.04.08
Japan’s New Requirement for Pediatric Drug Development Plans in PMDA Consultations
Introduction to Regulatory UpdateAccording to the news (PMDA 成人対象の治験相談でも「小児用医薬品の開発計画の有無を資料に記載」日薬連等に留意事項通知 | ニュ […]