2026.02.26
Japan Enhances Global Clinical Trial Access Through One-Stop Window and PMDA Collaboration
Introduction to the New Clinical Trial Initiative According to the official notification issued by Japan’s Min […]
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 […]
2025.09.30
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 […]
2025.08.26
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 […]
2025.01.21
Japan’s Upcoming Amendments to the Pharmaceutical and Medical Device Act
Japanese Pharmaceutical and Medical Device Act revisions aim to establish a pharmaceutical industry that ensures stable and reliable access to medicines for the public.