The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
The Ministry of Health, Labor and Welfare (MHLW) is set to reveal the draft of its second package strategy aimed at propelling the early commercialization of software as a medical device (SaMD) on September 6. The MHLW published its first…
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
- 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
REGULATORY
- MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
January 14, 2026
- Japan to Stick with 7 New Drug Approval Rounds a Year
January 14, 2026
- MHLW to Set Up Expert Panel on Using Disease Registries in Drug Development
January 13, 2026
- Chuikyo Moves to Allow Special Mixed-Billing for Santen’s Myopia Drug
January 13, 2026
- Japan Panel to Review AbbVie’s Aquipta, Ipsen’s Sohonos on January 23
January 13, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…