Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Approves Equa, Onglyza Generics towards December Listing, 1st DPP-4 Copycat on Horizon?
The Japanese health ministry on August 15 granted regulatory approval for a roster of generics ahead of the next biannual generic listing to take place in December. Eight APIs saw their first generic approvals, including the DPP-4 inhibitors Equa (vildagliptin)…
To read the full story
Related Article
- First Generics of Equa Priced at 30% of Original Product
December 6, 2024
- Xarelto, Equa Face Generic Debuts in Japan: December Listing
December 5, 2024
- Xarelto Copycats Earn Blessing, AG Might also Get on Board
August 19, 2024
- August Generic Approval List Includes AGs for at Least 3 APIs, Acofide and More
August 19, 2024
REGULATORY
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 2026
- Japan Panel to Review Haihe’s PI3Kα Inhibitor, MSD’s HIV Med, and More on March 2
February 24, 2026
- PM Vows Comprehensive Support for 17 Priority Sectors: Policy Speech
February 24, 2026
- Multiple Drug-Drug Interaction Risks under PMDA Review
February 24, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…