Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
Japan’s FY2024 drug pricing reform has prompted measurable upticks in development activity, with 31 products newly taken to the Pharmaceuticals and Medical Devices Agency (PMDA) for consultations and 20 products moving into clinical trial initiation, according to a new industry…
To read the full story
Related Article
REGULATORY
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
- MHLW Clarifies Up to 12-Year Data Protection for Pediatric Development
March 2, 2026
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…