JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
To read the full story
Related Article
- DT-Axis Charts Path to 2nd-Stage DTx Approval with Depression App
August 21, 2026
- 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
- 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
- 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
ORGANIZATION
- JPMA to Complete Shift to Legal Entity on October 1
September 30, 2026
- Generic Use Rate Hits Record 90.4% in April-June: JGA
September 30, 2026
- JaDHA Calls for Digital Health Seat in Chuikyo Reform
September 28, 2026
- Digital Health Group Eager to Gain Full Seat at Chuikyo Table
September 25, 2026
- Japan Wholesalers’ Profit Margin Worsens to 1.04% as Costs Rise
September 25, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





