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
LDP Lawmakers Want Specific Definitions for Emergency Approval Prerequisites
Lawmakers of the ruling Liberal Democratic Party (LDP) are calling for more specific definitions for the concept of “emergencies” and “no alternative products,” which are terms used to describe prerequisites that would trigger the proposed emergency approval scheme in Japan.…
To read the full story
Related Article
- MHLW Panel Urges Better Application of Emergency Approval
January 16, 2023
- Govt to Submit PMD Law Amendment Bill in Ordinary Diet Session to Introduce Emergency Approval
January 7, 2022
- MHLW Finalizes Paper on Emergency Approval System, Set to Submit Bill Next Year
December 28, 2021
- Japan to Revise PMD Law to Create Emergency Approval System, Final Paper Due Out by Year-End
December 23, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Japan Panel Discusses Safety, Immunity Rules for Envisaged Emergency Approval Scheme
November 19, 2021
REGULATORY
- Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
October 29, 2026
- FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
October 29, 2026
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
- Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
October 28, 2026
- Panel Member Urges Review of Tavneos Blue Letter Timing
October 28, 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…