Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
AMED Group to Draft Master Protocols Guidelines by March-End, Frets Further Drug Lag/Loss
A research group of the Japan Agency for Medical Research and Development (AMED) has initiated a project aimed at drawing up guidelines for master protocol studies, hoping to help streamline clinical trials conducted in Japan and thwart further drug lags…
To read the full story
REGULATORY
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 2026
- Growth Strategy Council WG Weighs Incentives for Clinical Trial Sites
March 17, 2026
- Gaku Hashimoto to Return as Skipper of LDP Team on Drug Innovation
March 17, 2026
- 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
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…