Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Eyes Mandatory Electronic Filings for NDA Clinical Trial Data from FY2016
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to require drug makers to submit clinical trial data for their new drug applications (NDAs) in electronic formats, beginning in FY2016—a move that would allow the authority to efficiently store and analyze…
To read the full story
REGULATORY
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
- Mounjaro Hit with 25% Price Cut under Japan’s “SPA-SSS” Re-Pricing
May 14, 2026
- Japan OKs Listing of Ambelvist, Dojolvi, Sohonos, and Finally Inrebic
May 14, 2026
- Chuikyo Clears NHI Listing for Amchepry, Akuugo, and Zolgensma Intrathecal
May 14, 2026
- Tepezza, Trodelvy Headed for NHI Price Cuts after CEAs
May 14, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…