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 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
- Government Unveils Four-Chapter Outline for 2026 Honebuto
June 26, 2026
- LDP, Ishin Leave Chuikyo Reform to Party Negotiators after Talks Stall
June 26, 2026
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…