Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Hands Out Orphan Designation to 11 Drugs
Japan’s Ministry of Health, Labor and Welfare (MHLW) on December 23 granted orphan drug designation to 11 compounds, including Regeneron Japan’s garetosmab and cemiplimab. Garetosmab was granted the status for the proposed indication of fibrodysplasia ossificans progressiva and cemiplimab for…
To read the full story
REGULATORY
- Japan OKs 2nd OTC Emergency Contraceptive, Launch Set for March 9
February 12, 2026
- LDP Wins Landslide Victory in Lower House Election; Ex-Lawmakers Return as Centrists Routed
February 9, 2026
- MHLW Panel Deems 10 “Drug Loss” Products as High-Need, to Seek Development
February 9, 2026
- MHLW to Allow OTC Drugs to Match Prescription Doses under Specific Conditions
February 5, 2026
- Japan Launches Biotechnology Working Group, Roadmap Draft Due in April
February 4, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…