PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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REGULATORY
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
- Japanese Health Minister Cautions Public on Multiple Measles Outbreaks
March 11, 2024
- PMDA Looks to Rev Up Pediatric and Orphan Drug Initiatives in Next 5-Year Plan: Chief
March 11, 2024
- MHLW Urges Distribution at Fair Price for Unprofitable Products
March 8, 2024
- New Govt Forum to Compile Interim Report to Create Innovation Ecosystem
March 8, 2024
- COVID Vaccine Labels to Be Updated with Booster Use as Main Regimen
March 8, 2024
- Japan Cabinet OKs Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
March 7, 2024
- New Govt Forum for Fighting Drug Loss Should Devise Strategies for Honebuto: LDP Members
March 6, 2024
- Xocova Approval Meaningful, but Careful Use Should Continue: Minister
March 6, 2024
- Opdivo Faces 15% Slash in Spillover, Re-Pricing to Hit 23 Drugs in FY2024 Revision
March 5, 2024
- Drug Prices Cut by 4.67% in FY2024 Revision, 314 APIs to Keep Full Prices with PMP
March 5, 2024
- Shionogi’s COVID Pill Xocova Lands Standard Approval in Japan
March 5, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- MHLW to Ask All Generic Makers in Japan to Execute Self-Inspections
March 4, 2024
- Japan’s Revised Drug Distribution Guidelines Take Effect
March 4, 2024
- PMDA Reviewing Safety Risks for 4 CAR-T Therapies and More
March 4, 2024
- Generic Mergers, Product Consolidations Unlikely to Pose Antitrust Issue: FTC Official
March 1, 2024
- Chugai’s PNH Med, Takeda’s cTTP Therapy Now in Line for Japan Approval
March 1, 2024
- Hospitals, Pharmacies Must Also Join Effort in Improving Drug Distribution: Expert Panel Member
February 29, 2024
- MHLW Sets Out to Beef Up Inspector Skills with Nationwide Sharing of GMP Reports
February 29, 2024
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Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…