Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Panel OKs Orphan Designation for Pfizer’s Hemophilia Gene Therapy
A key health ministry panel on June 1 agreed to grant orphan designation to Pfizer’s fidanacogene elaparvovec, a gene therapy for hemophilia B. The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Committee on Regenerative Medicine Products, Biological Products and Biotechnologies…
To read the full story
Related Article
- Pfizer Files Hemophilia B Gene Therapy in Japan
July 1, 2024
REGULATORY
- 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 Panel Backs Nonprescription Switch of Second Emergency Contraceptive
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…