Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Susmed’s Insomnia App in Line for Approval as Early as January
A Japanese health ministry advisory panel on December 19 recommended approval for a digital therapeutic app for insomnia developed by Tokyo-based health tech Susmed, opening the way for its green light as early as next month. The Pharmaceutical Affairs and…
To read the full story
Related Article
- Susmed Wins Partial Change Approval for Insomnia App, Seeks Coverage
September 8, 2025
- MHLW Panel to Further Review Positioning of Susmed’s Insomnia App
July 31, 2025
- Susmed Seeks Partial Change of Approval for Insomnia App towards Coverage
September 3, 2024
- Susmed Drops Reimbursement Request for Insomnia App
January 30, 2024
- Susmed Bags Japan Approval for Insomnia App
February 20, 2023
- Susmed’s Insomnia App Up for PAFSC Review on December 19
December 6, 2022
- Shionogi Gets Commercial Rights to Susmed’s Insomnia App
December 28, 2021
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 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…