The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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- HeartSheet’s Conditional Approval to Be Withdrawn as Early as August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
- LDP, Ishin Strike Deal on OTC-Like Drugs, Patients to Pay “1/4” Special Charge
December 22, 2025
- Japan Set to Raise Medical Fees by 3% in FY2026, Cut Drug Prices by 0.8%
December 22, 2025
- LDP, Ishin Finalize FY2026 Tax Reform Outline, Strategic Tech R&D Credit Codified
December 22, 2025
- OTC-Like Drugs Left in Limbo as Panel Debates Cost-Sharing without Clear Policy Signal
December 19, 2025
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence 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…