Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Begins Overhaul of Patent Linkage Framework with First Notification
Japan’s Ministry of Health, Labor and Welfare (MHLW) has taken the first step in a planned revamp of its patent linkage system, which determines whether generic and biosimilar applications conflict with existing patents. The effort began on October 8, when…
To read the full story
Related Article
- Japan Launches Pilot Expert Committee System for Patent Linkage Reviews, Aims to Reduce IP Feuds
November 17, 2025
- Japan Launches Study on Legal Framework for Patent Linkage System
October 9, 2025
- PhRMA Questions Utility of Proposed Expert Committee for Patent Linkage
May 8, 2025
- MHLW to Revise Patent Linkage Scheme in FY2025, Create Expert Committee
April 16, 2025
- MHLW Mulls System to Seek Expert Input for Patent Linkage
July 29, 2024
REGULATORY
- Japan to Delist 387 Drugs from NHI Price List, Including Renivace
February 16, 2026
- Chuikyo Payers Signal Mixed Views on Off-Year Drug Price Revisions
February 16, 2026
- Chuikyo Issues FY2026 Fee Revision Recommendation, Creates New Premiums for Generics and Biosimilars
February 16, 2026
- Japan Panel to Review Sumitomo, Cuorips iPSC Products on Feb. 19
February 16, 2026
- Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 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…