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
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…