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 cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Ken Yoshino

Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…

By Philip Carrigan

The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…

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…