Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
The Japanese health ministry is considering an amendment of its good clinical practice (GCP) ordinance with an eye towards incorporating the principle of a single institutional review board (IRB) per trial. The timeline for such changes is not yet determined.…
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 Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- New JPMA Task Force to Respond to ICH-GL and PMD Act Amendments
April 22, 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 Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
- JPMA Urges Foreign Price Rule Overhaul to Address US MFN Policy: LDP Hearing
November 5, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…