REGULATORY

After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures

By Tatsuya Otsuka August 22, 2022
In the wake of a series of manufacturing violations around the country, the Pharmaceuticals and Medical Devices Agency (PMDA) set up a dedicated division on GMP education support this April to improve the quality of onsite inspections by prefectural authorities.…

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REGULATORY

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

By Kohei Hori

Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…

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…