ORGANIZATION

JPMA Regulatory Chief Seeks Balanced Approach on Japanese PI Waivers

By Ken Yoshino September 3, 2025
Yuji Kashitani, chair of the Regulatory Affairs Committee at the Japan Pharmaceutical Manufacturers Association (JPMA), has cautioned that Japan’s recent shift toward waiving Japanese PI trials should not be misunderstood as making them unnecessary in all cases. “There is a…

To read the full story

Related Article

ORGANIZATION

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

By Shinya Sato

Japan is opening a new chapter in sleep medicine. The recent decision to allow medical institutions to advertise “sleep disorders”…

By Philip Carrigan

Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…

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…