Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) plans to introduce general-purpose AI during FY2025 to streamline administrative tasks such as drafting meeting minutes, while also exploring the longer-term use of more specialized AI for regulatory work. PMDA Senior Executive Director…
To read the full story
Related Article
- PMDA Lays Out AI Action Plan, Eyes Specialized In-House System
October 14, 2025
REGULATORY
- LDP Pharma Project Team to Compile Roadmap Proposals after Industry Hearings
April 17, 2026
- DPJ Leader to Urge Drug Price Hikes, “Freeze” on Off-Year Revisions
April 17, 2026
- War-Linked Supply Impact Cases Climb to 34 as Japan Steps Up Response
April 17, 2026
- Meiji Pharma Chair Prods Drug Price Hikes as War Drives Up Costs: Diet
April 17, 2026
- Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias
April 17, 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…