Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PAFSC 2nd Committee to Discuss Orphan Drug Designation for 3 APIs on Aug. 31
The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs, an advisory organ to the health minister, will discuss whether to recommend orphan drug designation for three active pharmaceutical ingredients (APIs) on August 31.The three APIs and proposed…
To read the full story
Related Article
REGULATORY
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
- Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
- MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
- MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
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…