Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
ORGANIZATION
JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
The Japan Digital Health Alliance (JaDHA) has drawn up a collection of hypothetical cases of therapeutic software as a medical device (SaMD) in a bid to add impetus to the development of these products envisioning the two-step approval pathway. JaDHA…
To read the full story
Related Article
- 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
- Boehringer’s Hasson Appointed EFPIA Japan Vice Chair
June 22, 2026
- Think Tank Opposes Cap on Social Security Burden Ratio, Urges Pause in Off-Year Price Cuts
June 22, 2026
- Japanese Drug Makers Step Up Use of ASEAN Reliance Reviews
June 18, 2026
- Ease Foreign Price Adjustment Rules for New Drugs to Counter MFN Policy: FPMAJ
June 15, 2026
- Raise Foreign Price Adjustment Cap for Listed Products in German Cases: FPMAJ
June 15, 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…