2026.06.24
Early Consideration on Clinical Evaluation of Factor VIII and Factor IX Products for Pediatric Congenital Hemophilia in Japan
Introduction to Pediatric Hemophilia Indication Development in Japan According to the communication issued by […]
2026.03.11
Revision of Q&A for preparing Pediatric Investigation Plans During Development of Adult Drug in Japan
Introduction to the Regulatory Update According to a notification issued by Japan’s Ministry of Health, Labour […]
2026.01.21
Japan Advances Regulatory Reforms on RWD Utilization, Conditional Approval, and Pediatric Drug Development
Introduction to Regulatory Revisions According to the notification issued by Japan’s Ministry of Health, Labou […]
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 […]
2025.08.26
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 […]
2025.04.08
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 […]