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…
REGULATORY
Orphan Designation System Should Be Adjusted for Factors Including Company Scale: Report
A study group backed by the Ministry of Health, Labor and Welfare has recommended in its report to change the existing orphan drug designation system to take into account factors including the number of patients and the scale of the…
To read the full story
Related Article
REGULATORY
- AbbVie’s Fast-Acting Botulinum Toxin Boey Wins Japan Panel Backing
October 27, 2026
- LDP Lawmakers Renew Push for Routine HPV Shots for Males by April 2027
October 27, 2026
- LDP Study Group Eyes Policy Proposals to Shore Up Drug Supplies
October 27, 2026
- FPMAJ Seeks Higher Drug Prices to Bolster Supply Security: LDP Confab
October 27, 2026
- PMDA Says IT Systems Could Go Offline Without Warning
October 27, 2026
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…