Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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 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 Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
- LDP, Ishin to Explore Role of Private Insurance in Reform Talks
April 14, 2026
- Middle East War Hitting API Air Freight, Trade Group Warns
April 13, 2026
- Japan’s 19th Pharmacopoeia Revision Takes Effect
April 13, 2026
- Voranigo and More Meds Missing from April Listing Slate; Servier Plans Packaging Change
April 10, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…