Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
Public-Private Collaboration Needed to Refine SaMD Regulatory System
A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…
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
- MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
August 31, 2023
- Chuikyo Subcommittee OKs Basic SaMD Reimbursement Rule
November 16, 2021
- PMDA’s SaMD Consultation Desk Handling 30 Inquiries per Month
November 16, 2021
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
- Japan Drug Makers Prepping to Launch New Organization to Solve Challenges in Digital Health
October 13, 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
COMMENTARY
- Adaptation, Diversification Key as Drug Wholesalers Face Profit Squeeze
June 16, 2026
- 20 Years at a Glance: Overseas Sales Surge at Japan Pharma, but R&D Investments Lag
June 9, 2026
- Are Technical Discussions Enough for Japan’s CEA System?
May 25, 2026
- Shift Underway in Pharma Workforce as Sales Roles Shrink, Manufacturing Rises
April 28, 2026
- Gene Therapies Expand into AMD, Raising Promise and Cost Concerns
April 24, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…