Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Nitrosamines Found in Duloxetine, Diltiazem; Panel Sets Intake Limits
A safety panel of Japan’s Ministry of Health, Labor and Welfare (MHLW) on April 24 set the acceptable intake limits after nitrosamines were detected in some products containing duloxetine HCl and diltiazem HCl. The detections were made during self-inspections conducted…
To read the full story
REGULATORY
- AstraZeneca’s Oral SERD, MSD RSV Antibody Up for Japan Panel Review on May 25
May 12, 2026
- Daiichi Sankyo Wins Japan Approval for MMR Vaccine Mimrit
May 12, 2026
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…