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
- Japan to Announce New Drug Prices on March 5
February 15, 2024
- AMED Chief Eyes 20-30% Team Expansion by FY2029
February 14, 2024
- Sawai and Kaigen Submit Biz Improvement Plans to Osaka Govt
February 14, 2024
- MHLW to Review Pig Kidney Transplant Plan Including Ethical Issues: Minister
February 14, 2024
- Chuikyo Issues 2024 Reform Recommendation; 1,000 Yen Premium Set for Inpatient Biosimilar Use
February 14, 2024
- Active Pharma Slapped with Biz Improvement Order for Illicit API Production
February 13, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
- Maintain Funding for COVID Pill beyond April: Academic Societies to Govt
February 13, 2024
- Japan Approves Jardiance for CKD, Label Expansion for Opdivo and More
February 13, 2024
- Japan to Allow Submissions without Japanese Data If All Requirements Met
February 9, 2024
- FPMAJ Supports Generic Industry Consortia Concept but Frets Antitrust Issues
February 9, 2024
- Health Minister Admits Antitrust Challenge in Generic Industry Revamp
February 9, 2024
- Takeda’s Acquired Hemophilia A Drug Up for Panel Review on February 22
February 9, 2024
- New Govt Forum Moots US-Level Trial Environment, Priority Review Vouchers
February 9, 2024
- Generic Panel to Issue Report in Spring-Summer to Drive Manufacturing Efficiency towards Stable Supplies: Official
February 8, 2024
- Japan to Revamp Scheme for Drug Maker’s Reporting of Supply Concerns in April
February 7, 2024
- Legal Changes on Horizon for GMP Inspection Authorities, Other Regulation Panel Topics?
February 7, 2024
- Govt Eyes Boosted Manpower at AMED towards Next 5-Year Plan from FY2025
February 7, 2024
- AMED Needs More Manpower to Fulfill Its Role as Funding Agency: President
February 6, 2024
- Opdivo, Olumiant, Dupixent Now in Line for Label Expansions
February 6, 2024
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The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…