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 Offer Priority Consultations for Overseas Startups
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will begin offering priority face-to-face consultations on domestic clinical trials for overseas startups, with the health ministry issuing a notification on February 10 outlining eligibility criteria. According to the notice, eligible products must…
To read the full story
REGULATORY
- CEA Review Group Holds First Meeting, Technical Debate Yet to Begin
May 26, 2026
- US Calls Out Japan’s Market Expansion Re-Pricing Rules as “Unfair”: IP Report
May 26, 2026
- Japan Mulls Target on “Social Security Burden Rate” after CEFP Call
May 25, 2026
- Ishin Deepens Debate on Healthcare Macroeconomic Indexing
May 25, 2026
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 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…