2026.04.13
PMDA Early Consideration on Clinical Trials with a Limited Number of Subjects: Key Considerations for Drug Development in Japan
Introduction to Small Sample Clinical TrialsAccording to the notification issued by the Pharmaceuticals and Me […]
2026.03.31
Points to Consider for Clinical Development of PSMA-PET Radiopharmaceuticals in Japan
Introduction to Regulatory Considerations According to the document issued by the Pharmaceuticals and Medical […]
2026.02.17
Points to Consider for the Development of Drugs for Hypertrophic Cardiomyopathy (Early Consideration)
Introduction Hypertrophic cardiomyopathy (HCM) is a condition marked by abnormal thickening of the ventricular […]
2026.02.04
Points to Consider for the Efficacy Evaluation of Drugs for IgA Nephropathy (Early Consideration)
Introduction to Regulatory Considerations According to the document “Points to Consider for the Efficacy Evalu […]
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 […]