Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
Members of the government’s regulatory reform promotion council on December 25 called for clarifying the standards for confirming the efficacy of software as a medical device (SaMD) under the two-stage approval system for these products. In November, the Ministry of…
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
- SaMD Could Be Eligible for 2-Stage Approval System: MHLW
June 1, 2023
- Push SaMDs from Industrial Policy Viewpoint: Deregulation Panel Member
April 18, 2023
- Japan Deregulation Panel Proposes Two-Step Approval Scheme for SaMD
December 23, 2022
- Early Approval, Reimbursement of SaMD Put on Priority Agenda: Deregulation Panel
October 25, 2022
REGULATORY
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
- MHLW Panel Backs Easing Protopic Contraindication for Young Children
September 30, 2026
- PMDA Flags New Safety Risks with 3 Drugs
September 30, 2026
- CEA Transparency Gains Welcome, but Guidelines Need Scrutiny: Economist
September 30, 2026
- More Company Involvement in CEA a Big Positive: C2H Researcher
September 29, 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…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…