Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026 drug pricing reform, with pharma groups again pressing to abolish both the “special” market expansion re-pricing scheme and the “spillover”…
To read the full story
Related Article
- Japan Ministers Agree to Scrap “Spillover” Rule, Plan Wider CEA Price Cuts
December 25, 2025
- Japan Weighs Scrapping “Spillover” Rule in Shift from Draft Reform Outline
December 24, 2025
- Pharma Groups Reiterate “No” to Broader CEA Use, Huge-Seller and Spillover Rules: Joint Statement
December 17, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- MHLW Proposes Pricing New AGs and Bio-AGs on Par with Originators
December 4, 2025
- FY2026 Reform Roadmap Keeps Key Drug Pricing Issues on Ice, Snubs Many Industry Requests: Chuikyo
December 4, 2025
- Pharma Groups Renew Push for Price Stability During Patent Term as FY2026 Reform Talks Begin
July 10, 2025
REGULATORY
- 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
- MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
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…