Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Issues ICH E19-Based Guideline on Selective Approach to Safety Data Collection in Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) has issued a new guideline on safety data collection from late-stage and post-registration clinical trials. Based on the ICH’s E19 Guideline, the new guidance is expected to facilitate the efficient conduct of…
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…