Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
ORGANIZATION
FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
Quick Look: FIRM warns that Japan's plan to halve profit margins for conditionally approved regenerative medicines could weaken incentives for development. Chairman Kenichiro Hata says pricing must reflect the patient-specific nature of therapies such as autologous cell products. ----- Japan’s…
To read the full story
Related Article
- BCG’s Takeda Questions Conditional Pricing for Regenerative Medicines
March 25, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- FIRM Urges Continued Premiums for Conditionally Approved Regenerative Medicines
October 30, 2025
- Chuikyo Urges Stricter Pricing Rules for Conditionally Approved Regenerative Medicines
October 16, 2025
- Japan Puts a Hold on Coverage Discussions for Elevidys over Safety Concerns
June 19, 2025
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
- It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
March 27, 2025
- Chuikyo Urges Rethink of Health Coverage for Conditionally Approved Regenerative Medicines
August 9, 2024
- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August
July 26, 2024
- Terumo to End Sale of HeartSheet after Panel’s Thumbs-Down
July 22, 2024
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
- Payer Chides AnGes’s Course Change on Collategene, Urges Re-Think of System’s Set-Up
July 4, 2024
- AnGes Alters Strategy for Collategene, Halts Japan Sales for Fresh Submission
June 25, 2024
ORGANIZATION
- Japan Generics Society Calls for Risk-Based Nitrosamine Controls
October 16, 2026
- Japan Expert Calls for Earlier Access to Anti-Obesity Drugs
October 16, 2026
- Japan Falling Behind US, China in Pharma Innovation, EFPIA Chief Urges Action
October 15, 2026
- US VC Coalition Urges Japan to Rethink Drug Pricing, Labor Rules
October 13, 2026
- PhRMA Sues CMS over Medicare MFN Model, Calls It Unlawful Overreach
October 9, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…