Japan’s general trading houses are steadily becoming a force to be reckoned with in the pharmaceutical industry — and not…
REGULATORY
MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
The Ministry of Health, Labor and Welfare (MHLW) is set to reveal the draft of its second package strategy aimed at propelling the early commercialization of software as a medical device (SaMD) on September 6. The MHLW published its first…
To read the full story
Related Article
- JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
October 11, 2024
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
October 3, 2023
- Japan Unveils 2nd Package Strategy for SaMD
September 7, 2023
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 2021
- MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
June 18, 2021
- MHLW Launches New Office to Fuel SaMD Commercialization
April 6, 2021
- MHLW Formulates Package Strategy for SaMD Commercialization, Eyes Sakigake Scheme
November 26, 2020
REGULATORY
- 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
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Industry Opposes Deeper CEA Price Cuts for “Cost-Increase” Products
November 13, 2025
- Pharma, Wholesalers Urge Drug Pricing Overhaul to Address Inflation: LDP Hearing
November 13, 2025
A public-private council report outlining industry views on Japan’s drug pricing systems drew little discussion at a meeting of the…
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…