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
- LDP Panel Chief Calls for Earlier CGP Coverage in Cancer Care
September 4, 2026
- Japan to Revisit Handling of Steroid Creams under OTC-Like Drug Charge
September 4, 2026
- UK Halts Tavneos for New Patients, Approval Revocation Set for March
September 4, 2026
- Japan Picks 5 COVID Vaccines for NIP Use from October
September 3, 2026
- New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
September 3, 2026
Japan has entered a third straight year of wage hikes averaging 5%, but the pharmaceutical industry is struggling to keep…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…