Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
COMMENTARY
With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
In early September, Japan released its second package strategy for software as a medical device (SaMD), dubbed “DASH for SaMD 2”. With new measures added to its first edition compiled in 2020, the new strategy embraces “predictability” and “international expansion”…
To read the full story
Related Article
- JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
October 11, 2024
- Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
December 27, 2023
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 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
- SaMD Could Be Eligible for 2-Stage Approval System: MHLW
June 1, 2023
- Japan Deregulation Panel Proposes Two-Step Approval Scheme for SaMD
December 23, 2022
- 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
COMMENTARY
- MOF Autumn Proposals Signal a Shift from Drug Pricing to Cost-Sharing Reform
November 17, 2025
- Japan’s Trading Houses Gain Ground in Pharma, Rewriting the Industry Playbook
November 10, 2025
- The Price of Stability: Who Bears Japan’s Drug Distribution Burden?
October 27, 2025
- Inside Eylea - 2: Will a Bio-AG Return after Six Years? Pricing Debate Resumes
October 7, 2025
- Inside Eylea - 1: Patent Issues Behind Differences in Biosimilar Indications for AMD and DME
October 6, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…