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 FY2026 Budget Request to Focus on Clinical Trials, Early Regulatory Support
August 21, 2025
- Japan Moves to Bolster R&D and Stockpiling of Crisis-Response Medicines
August 20, 2025
- Astellas’ Izervay, Otsuka’s Nexletol among New Drugs Up for Japan Panel Review; Eylea Biosimilars Also on Agenda
August 19, 2025
- MHLW Official Vows Steady Implementation of Amended PMD Act
August 19, 2025
- Japan Weighs Legal Framework for Pharmaceutical Data Protection; JPMA Sees Opportunity for Reform
August 19, 2025
- MHLW’s New Pharma Chief Pledges Safer, More Accessible Drug Environment
August 19, 2025
- Nipro Secures AG for Forxiga, Sawai and Teva Takeda Go Without Hydrate
August 18, 2025
- Japan Approves First SGLT2 Generics, 12 Firms Pile into Vimpat Ahead of December Listing
August 18, 2025
- MHLW Working Group Sets Policy for Revising List of “Stable Supply Medicines”
August 18, 2025
- Novartis’ Radioligand Therapy, Other New Meds Up for Japan Panel Review on Aug. 22
August 12, 2025
- Japan Nears Approval for 1st Biosimilars of Actemra, Simponi, and Ranmark
August 12, 2025
- Japan Approves FY2026 Budget Guidelines, Natural Increase at 400 Billion Yen
August 12, 2025
- PMDA Flags New Potential Risks for RAS Agents and Others
August 12, 2025
- Japan Approves MSD’s 21-Valent Pneumococcal Vaccine
August 8, 2025
- Public-Private Council WG to Focus on Innovation Evaluation for FY2026 Reform: Official
August 8, 2025
- Chuikyo Approves Insurance Coverage for 4 In Vitro Diagnostics
August 8, 2025
- Japan to Discuss Negative Margins, Packaging Optimization towards FY2026 Reform
August 8, 2025
- Medical Device Pricing Body Urges Clearer Evaluation Criteria for SaMDs Reimbursement
August 8, 2025
- Industry Urges “Objective Review First” for CEA Reform; Payers Push for Expansion
August 7, 2025
- Welireg, Airwin, Talvey and More Set for NHI Listing; Premiums Wiped Out by “Zero” Rule
August 7, 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,…
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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…