Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- 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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
- FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
February 3, 2026
- AMDD to Continue Policy Advocacy to Address Device Lag and Loss: Chair
January 28, 2026
- Off-Year Drug Price Revisions Run Counter to Innovation, JPMA Exec Says
January 23, 2026
- Kobe, iPark Institute, Partners Sign Pact to Accelerate Innovation at KBIC
January 21, 2026
- OTC Industry Head Urges Caution on Extra Charges for “OTC-Like” Drugs
January 20, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
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…