Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Review Period Reduced for Both Priority, Standard Products
At a meeting of its Review and Safety Committee on December 26, the Pharmaceuticals and Medical Devices Agency (PMDA) reported the latest status of the new drug application (NDA) review and trend of safety measures in the first half of…
To read the full story
REGULATORY
- 874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
- Truqap Price Cut Set at 10.7% from June under CEA Scheme
March 12, 2026
- Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…