2025.12.09
Japan’s Early Consideration on Nonclinical Requirements for Similar-Formula Prescription Combination Products
Introduction to the PMDA’s New Guidance According to the information released by Japan’s Pharmaceuticals and M […]
2025.11.26
PMDA Issues Early Considerations for Clinical Development of Psoriatic Arthritis (PsA) Treatments in Japan
Introduction to the Early Consideration Document According to the PMDA’s early consideration document (publish […]
2025.11.21
Japan’s PMDA Introduces Early Considerations on WOE-Based Nonclinical Safety Assessment and Reduced Reliance on Non-Human Primates
Introduction: PMDA’s Shift Toward Scientific Flexibility and 3Rs According to two early-consideration document […]
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 […]
2025.04.08
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 […]