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 […]
2025.08.26
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 […]