Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Issue Development Requests for New Indications for 6 Meds including Stivarga
A council of the Ministry of Health, Labor and Welfare (MHLW) determined on December 21 that there are high medical needs for six APIs, including Bayer Yakuhin’s Stivarga (regorafenib). The MHLW will now issue development requests to each relevant drug…
To read the full story
REGULATORY
- Cabinet-Backed Health Insurance Bill Targets Childbirth Costs, Copay Reform
March 16, 2026
- Japan Cabinet Approves Health Insurance Bill with OTC-Like Drug Charges
March 16, 2026
- LDP Urges Action on Drug Supply Risks Linked to Reliance on Specific Countries
March 16, 2026
- 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
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…