Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Panel Discusses Potential Waiver of Japanese Trials for Ultra-Orphan Medicines
A health ministry panel on pharmaceutical regulations on December 13 discussed the need for confirmatory trial data in Japanese subjects for drugs to treat ultra-rare diseases. The industry proposed waving the implementation of Japanese studies when deemed appropriate in a…
To read the full story
Related Article
REGULATORY
- DPJ Leader to Urge Drug Price Hikes, “Freeze” on Off-Year Revisions
April 17, 2026
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
- MHLW to Set Criteria for Exemptions under OTC-Like Drug Charge Scheme
April 16, 2026
- MHLW Taps Kawabata to Lead Drug Discovery Support Office
April 15, 2026
- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
April 15, 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…