2026.07.07
What scientific rationale and supporting evidence are required to substantiate the classification of a genetic alteration as a driver mutation in the development of Anti-cancer Drugs ?
Introduction to PMDA’s Early Consideration on Driver Mutations According to the Early Consideration docu […]
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 […]
2026.06.08
Considerations for Determining the Need for Comparative Efficacy Studies in Biosimilar Development in Japan
Introduction to PMDA’s Early Consideration on Comparative Efficacy Studies for Biosimilars According to the Ea […]
2026.05.13
Early Consideration on Clinical Development of In Vivo Diagnostic Drugs in Japan
Introduction to Early Consideration on In Vivo Diagnostic Drug DevelopmentAccording to the Early Consideration […]
2026.04.27
Early Consideration on Food Effect Evaluation for Oral Drug Products in Japan
Introduction to Early Consideration on Food Effect Evaluation According to the notification issued by Pharmace […]
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 […]