LEXICON
No.125 September 10, 2012

GPMSP (good post-marketing surveillance practice)
医薬品の市販後調査の基準
GPSP (good post-marketing study practice)
医薬品の製造販売後の調査及び試験の実施の基準
GVP (good vigilance practice)
医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準

The amended Pharmaceutical Affairs Law (PAL; 薬事法), which went into full effect on April 1, 2005, divided post-marketing surveillance (PMS; 市販後調査), which had been conducted in accordance with the GPMSP (good post-marketing surveillance practice) standards (医薬品の市販後調査の基準), into 1) post-marketing drug...

To read the full story

LEXICON

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…