Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Urges Drug Makers to Boost Manufacturing Control after Itraconazole Issue
After Kobayashi Kako’s antifungal agent itraconazole was found to have been tainted with the sleep inducer rilmazafone, the Ministry of Health, Labor and Welfare (MHLW) issued a notification on December 11, urging drug makers to ramp up their manufacturing management…
To read the full story
Related Article
REGULATORY
- Wegovy’s MASH Label Expansion and More Up for Japan Panel Review on May 29
May 18, 2026
- Japan Eyes June Submission of Immunization Act Bill to Cover Antibody Drugs
May 18, 2026
- Calls Grow for Japan Version of EHDS at Regulatory Reform Panel
May 18, 2026
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 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…