2026.10.09
Early Consideration on General Toxicity Evaluation of Monoclonal Antibodies in Japan
Introduction to General Toxicity Evaluation of Monoclonal Antibodies On May 13, 2026, the Pharmaceuticals and […]
2026.09.15
Japan Joins FDA’s Project Orbis to Accelerate Global Oncology Drug Approvals
Introduction to Project Orbis is an international regulatory collaboration program established by the FDA Onco […]
2026.09.08
Comparison of Biosimilar Development Guidelines: Japan, EU, and United States
Overview This document provides a comparative analysis of biosimilar regulatory guidelines across Japan (PMDA/ […]
2026.08.17
Early Consideration on Safety Measures for Bioequivalence Studies in Healthy Volunteers in Generic Drug Development in Japan
Introduction to Safety Considerations for Bioequivalence Studies According to the notification issued by the P […]
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 […]