Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Pushes Back GCP Ordinance Revision to Summer
Japan’s planned revision of its Good Clinical Practice (GCP) ministerial ordinance will now be promulgated around this summer, later than previously expected, according to the Ministry of Health, Labor and Welfare (MHLW). Speaking at a Pharmaceuticals and Medical Devices Agency…
To read the full story
Related Article
- MHLW Plans to Ease Clinical Trial Ad Rules, Eyes Notification by March-End
July 24, 2025
- New JPMA Task Force to Respond to ICH-GL and PMD Act Amendments
April 22, 2025
- Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
April 3, 2025
- Include Single IRB Policy in GCP to Accelerate Trials: EFPIA Official
February 10, 2025
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
REGULATORY
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- Public Comments Warn Japan’s Drug Pricing System Cannot Reflect Inflation: Chuikyo
February 2, 2026
- Chuikyo Agrees to Apply Originator Optimal-Use Guidelines to Biosimilars
February 2, 2026
- MHLW Panel Sets Safety Rules for Upcoming Pomalyst Generics
February 2, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
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,…
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…