As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
REGULATORY
MHLW to Disclose Review Reports for Conditionally Cleared Regenerative Therapies Even If Full Approval Bid Dropped
The Ministry of Health, Labor and Welfare (MHLW) has issued new guidance clarifying that review reports for regenerative medicine products cleared under conditional and time-limited approval will be made public even if companies withdraw their applications for full approval. The…
To read the full story
REGULATORY
- Japan Launches Pilot Expert Committee System for Patent Linkage Reviews, Aims to Reduce IP Feuds
November 17, 2025
- Chuikyo Split over Higher Copays under LLP Scheme; Payer Push Meets Provider Caution
November 17, 2025
- Elrexfio to Escape CEA-Based Price Tweak, Analysis to Resume for Paxlovid
November 17, 2025
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
Japan is set to tighten reimbursement rules for regenerative medicine products granted conditional, time-limited approval, with Central Social Insurance Medical…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
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…