LEXICON
No.22 November 8, 2010

Paper-based compliance inspection
適合性書面調査
On-site compliance inspection
適合性実地調査

適合性書面調査: Raw data (生データ) and other source documents (原資料) are inspected by the PMDA (Pharmaceuticals and Medical Devices Agency; 医薬品医療機器総合機構) to determine whether studies based on which non-clinical and clinical data attached to applications for new drugs and medical devices...

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 Tatsuya Otsuka

Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…

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…