REGULATORY

MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations

December 16, 2025
Japan’s health ministry will introduce a new pathway from May 2026 allowing drug makers to ask the Pharmaceuticals and Medical Devices Agency (PMDA) to assess whether a product qualifies as a “drug for specific use.” “Drugs for specific use” is…

To read the full story

Related Article

REGULATORY

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Philip Carrigan

The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…

By Shinya Sato

The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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…