The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
A key Japanese reimbursement policy panel will reexamine the general set-up of health coverage under the current conditional time-limited approval pathway for regenerative medicinal products, beginning this fall. The plan comes after two recent cases of conditionally approved products failing…
To read the full story
Related Article
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Chuikyo Urges Stricter Pricing Rules for Conditionally Approved Regenerative Medicines
October 16, 2025
- Elevidys Coverage Debate to Resume after MHLW Gains Broad Understanding on Safety
October 9, 2025
- MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure
September 1, 2025
- Chugai to Defer Domestic Supply of Elevidys amid Safety Review
July 25, 2025
- Japan Puts a Hold on Coverage Discussions for Elevidys over Safety Concerns
June 19, 2025
- Chugai’s DMD Gene Therapy Snags Conditional Approval in Japan
May 14, 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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
REGULATORY
- MHLW Pharma Director Says Uniform Drug Price Hike “Not Realistic,” Targeted Support Preferred
January 9, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
January 6, 2026
- Ex-JPMA President Ueno Takes on New AMED Advisor Role
January 6, 2026
- Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
January 5, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…