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
- Challenges in a Post-AG Era: Ensuring a Reliable Supply System
April 6, 2026
- Japan’s FY2026 R&D Tax Credit Reform Wins Broad Industry Backing
April 1, 2026
- A “Core Industry” in Name Only? Drug Pricing Reform Leaves a Sour Taste
March 24, 2026
- Beyond Elevidys: Next-Generation DMD Therapies Advance through Multiple Approaches
March 11, 2026
- Elevidys Opens New Era for DMD Treatments Targeting the Underlying Cause
March 10, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…