Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
“Huge Seller” Re-Pricing to Hit Sovaldi, 3 Other Brands; Hefty 20 APIs Face Regular Market Expansion Re-Pricing
As widely expected by the industry, a new special re-pricing rule for fast-growing blockbusters will be applied to Gilead Sciences’s hepatitis C antiviral Sovaldi (sofosbuvir) in April, the Ministry of Health, Labor and Welfare (MHLW) revealed on January 20. A…
To read the full story
Related Article
- Bill Payer Proposes “Penalties through NHI Prices” for Violations of Pharma Law in Wake of Kaketsuken Scandal: Chuikyo
January 22, 2016
- 4 Listed Drugs plus Similar Products Subject to Cost-Effectiveness Review: Chuikyo
January 21, 2016
- Chuikyo OKs New Drug Pricing Rules for FY2016 Reform; Sakigake-Designated Add’l Indications Also Subject to Premiums
January 21, 2016
- MHLW to Designate 617 Products/134 APIs as “Essential Drugs”: Will Receive Uniform, Stable NHI Prices, Exempt from Z2 Rule
January 21, 2016
REGULATORY
- LDP, Ishin Call for Proper Valuation in CEA Scheme at Reform Talks
April 3, 2026
- MHLW Revises Biological Raw Material Rules, Clarifies Donor Testing Flexibility
April 2, 2026
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
Japan will overhaul its R&D tax credit regime in its FY2026 reform, introducing a new strategic category alongside existing frameworks.…
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
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…