2026.08.12
Early Consideration for the Revision of Japan’s Regulatory Guidelines on Prototype Vaccines for Pandemic Influenza Preparedness
Introduction to the Early Consideration On July 31, 2026, Japan’s Pharmaceuticals and Medical Devices Agency ( […]
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 […]
2026.05.27
Q&A on Japan’s Conditional Approval Policies for Pharmaceuticals: Key Clarifications for Global Drug Developers
Introduction to Japan’s Conditional Approval Q&A According to the Q&A document issued by Japan’s Minis […]
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 […]
2026.03.11
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 […]