Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Japan Moves to Bar Duplicate IRB Reviews under Single-IRB Framework
July 23, 2026
- MHLW Official Urges Proper IRB Selection under New GCP Rules
June 12, 2026
- Japan Panel Slams MHLW’s 80% Single-IRB Target as Too Low
March 24, 2026
- 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
- Japan Panel Again Defers Male HPV Shots amid Cost-Effectiveness Concerns
October 9, 2026
- Takaichi Defends Off-Year Drug Price Revisions as DPP Calls for Abolition
October 9, 2026
- Japan Orders Contraindication for Adlumiz-Noxafil Combination
October 9, 2026
- Imcivree, Hibsago Get Chuikyo Nod for Home Self-Injection
October 9, 2026
- Provider-Payer Tug-of-War Takes Shape over FY2027 Drug Price Revision
October 8, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…