Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Says Trial Recruitment Info Not Deemed Advertising Under PMD Act
Japan’s Ministry of Health, Labor and Welfare (MHLW) has clarified that information provided to recruit participants for clinical trials will not be considered “advertising” under the Pharmaceuticals and Medical Devices (PMD) Act if limited to what is necessary for recruitment.…
To read the full story
Related Article
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Plans to Ease Clinical Trial Ad Rules, Eyes Notification by March-End
July 24, 2025
- Regulatory Reform Panel Calls for Review of Clinical Trial Ad Rules
May 30, 2025
- Clinical Trial Matching Websites Do Not Violate Ad Regulations in PMD Act: MHLW
April 10, 2025
- Revise Regulations of Clinical Trial Info in PMD Act: Patient Advocate to Diet
April 9, 2025
- Govt’s Regulatory Reform Panel Discusses Access to Clinical Trial Information
March 7, 2025
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
- Panel Questions Timing of Tavneos Blue Letter Action
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’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…