Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel Backs “Sakigake” Influenza Drug; Possibility of Accelerated Approval and Listing Unclear
The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council, a de-facto decision-making body for marketing approval, recommended approval on February 2 for Shionogi’s influenza type A/B treatment baloxavir marboxil, which has been designated for priority review…
To read the full story
Related Article
- Shionogi’s Single-Dose Flu Med Xofluza Hits Japan Shelves
March 15, 2018
- Xofluza to Join NHI Price List March 14 as Key Panel Gives Expedited OK
March 7, 2018
- Shionogi’s Single-Dose Flu Med Gets Accelerated OK
February 26, 2018
- Japan’s 1st Herceptin Biosimilar Clears MHLW Panel, Now in Line for March Approval for Gastric Cancer
February 5, 2018
- Shionogi’s Sakigake-Designated Flu Med Up for MHLW Panel Review on Feb. 2, Early Listing Possible?
January 23, 2018
REGULATORY
- Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
June 12, 2026
- Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
June 12, 2026
- iPark CEO Calls for National AI Drug Discovery Platform at LDP Hearing
June 12, 2026
- MHLW Official Urges Proper IRB Selection under New GCP Rules
June 12, 2026
- MHLW Panel Weighs Single IRB, DCT Metrics in Core Hospital Overhaul
June 12, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…