Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias
Japan’s Ministry of Health, Labor and Welfare (MHLW) has streamlined the approval application requirements for pharmaceutical excipients manufactured overseas in line with US and European pharmacopoeias. Under the revision, excipients produced based on the US Pharmacopeia-National Formulary (USP-NF) or the…
To read the full story
Related Article
REGULATORY
- CEA Review Group Discusses Evidence for Additional Usefulness
June 17, 2026
- Japan Sets 6-Billion-Yen Donation Target for Drug Discovery Fund
June 17, 2026
- Minister Signals Chuikyo Review of Innovation Incentives after Roadmap
June 17, 2026
- MHLW Issues Guidance on Proper Use of GLP-1 Drugs
June 17, 2026
- Japan Panel Seeks Easing of Rules on Radiopharma Research Samples
June 16, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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 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…