Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
7 Generic API Specifications Subject to New Rule to Address Unreasonable Price Rises
Seven generic "API specifications" will become subject to a new rule that will be introduced in April to create separate price bands for listed generics as a way to address unreasonable price rises for cheaply sold products, according to the…
To read the full story
Related Article
- 3 Drugs Earn Post-Launch “True Clinical Utility” Premium; Forxiga Price Flat, Rises for Canaglu and Praluent
March 5, 2020
- Price Maintenance Premium Granted to 335 APIs/555 Products; Novartis Top PMP Earner
March 5, 2020
- With 80%-Plus Gx Rates, Many One-Time Blockbusters Might Be In for Earlier “G1” Price Cuts
March 5, 2020
- Xolair Faces 37.3% Price Slash, Keytruda 20.9% in April: MHLW
March 5, 2020
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…