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 1st Generics for 4 APIs towards June Listing, All See AGs
The Ministry of Health, Labor and Welfare (MHLW) on February 15 approved a raft of generic medicines towards the next biannual generic listing in June, including first copycat products for four APIs. This is the first time since August 2020…
To read the full story
Related Article
- Clenafin Authorized Generic Hits Japan Market: Kaken
September 16, 2025
- EquMet, Clenafin See Generic Entry in June Listing
June 12, 2025
- Bridion Generic Vials Hit Market in Droves at 32% of Originator Price
June 14, 2024
- First Generics Joining NHI Price List in June Hits Record Low, Bridion is Only Target
June 14, 2024
- Bridion Sees Rare May Generic Entry for New Dosage Form in Japan
May 21, 2024
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…