2026.01.21
Japan Advances Regulatory Reforms on RWD Utilization, Conditional Approval, and Pediatric Drug Development
Introduction to Regulatory Revisions According to the notification issued by Japan’s Ministry of Health, Labou […]
2025.12.25
Joint Industry Statement Calls for Reform of Japan’s FY2026 NHI Drug Pricing and Cost-Effectiveness Assessment System
Introduction to Policy DiscussionAccording to a joint statement (Joint Statement on Need for FY2026 NHI Drug P […]
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 […]
2025.10.17
Japan’s Early Consideration on Handling of Japanese Data for Biosimilar Comparability
Introduction to Regulatory Perspective According to the PMDA’s provisional translation released on September 1 […]
2025.09.30
Key Takeaways from the PMDA Symposium on Japanese Phase I Trials Before MRCT Participation
Introduction On August 4, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) hosted a public symposiu […]
2025.09.17
PMDA Symposium 2025: Key Takeaways for Pediatric Drug Development
IntroductionOn August 27, 2025, the PMDA hosted a symposium titled “Toward Enhanced Pediatric Pharmacotherapy […]
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 […]
2025.08.05
Otsuka Holdings Accelerates Mid- to Long-Term Strategy in Autoimmune Diseases with 8 Development Programs
Introduction to Strategic Focus on Autoimmune Diseases According to a news article (大塚HD・井上社長兼CEO 自己免疫領域に８つの開発 […]