Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
Japan’s Ministry of Health, Labor and Welfare (MHLW) has issued a revised notification on the preparation of pediatric drug development plans ahead of the May 1 enforcement of the amended Pharmaceuticals and Medical Devices (PMD) Act. The updated guidance, sent…
To read the full story
Related Article
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
REGULATORY
- 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
- Health Insurance Reform Bill Enters Diet Debate; OTC-Like Drug Charges in Focus
April 10, 2026
- CEPI Seeks Continued Technology, Funding Ties with Japan
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…