Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure
September 1, 2025
- Japan Doles Out Orphan Tags to Ultragenyx’s GTX-102 and Lots More
September 1, 2025
- Japan Expects COVID Vaccine Supply of 9 Million Doses in 2025-26
September 1, 2025
- Japan Govt to Spearhead Development of Ultra-Orphan and Infectious Disease Drugs: FY2026 MHLW Budget Request
August 29, 2025
- Japan Moves Toward OTC Morning-After Pill Sales Without Age Limit or Parental Consent
August 29, 2025
- Diagnostics Industry Urges Mechanism to Reflect Rising Costs in Reimbursement
August 29, 2025
- Japan to Expand List of “Stable Supply Medicines” to 759 APIs, Adding Vaccines and Blood Products
August 28, 2025
- Japan to Apply Drug Pricing Rules for Krystal Gene Therapy: Chuikyo
August 28, 2025
- MHLW's FY2026 Budget Bid Prioritizes Innovation, Stockpiles, Ultra-Orphan Support
August 27, 2025
- MHLW Pharma Bureau Seeks FY2026 Budget to Bolster PMDA and Speed Up SaMD Reviews
August 27, 2025
- MHLW Seeks New R&D Tax Credit Scheme for Strategic Technologies in FY2026 Proposal
August 27, 2025
- Public-Private Council WG on Drug Discovery to Hold First Meeting Sept. 1
August 26, 2025
- Japan Approves 3 New Drugs, Expands Label for Enhertu, Silgard 9 and More
August 26, 2025
- No Inflation Measures for Drugs Mentioned in FY2026 Budget Request: MHLW Draft
August 25, 2025
- MHLW Panel Endorses Orphan Tag for 2 Regenerative Medicine Products
August 25, 2025
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
- Vonoprazan Gets Panel Backing for Rx-to-OTC Switch
August 25, 2025
- PMDA’s “Early Considerations” Start to Pay Off with Faster Reviews
August 22, 2025
- Japan Mulls Preferential R&D Tax Credits for Strategic Technologies in FY2026 Reform Talks
August 22, 2025
- AMED to Put Practicality First in Project Selection: Ecosystem Coordinator
August 21, 2025
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…