Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Regulatory Reform Panel Urges Better Trial Environment, SaMD Review
The government’s Regulatory Reform Promotion Council on December 22 compiled a paper listing near-term regulatory reform initiatives and proposals, calling for deregulations to facilitate clinical trials and revise the review process for software as a medical device (SaMD). In the…
To read the full story
Related Article
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
- Deregulation Panel Prods Govt to Fuel SaMD Development
June 3, 2021
REGULATORY
- Japan Panel Slams MHLW’s 80% Single-IRB Target as Too Low
March 24, 2026
- Ishin Proposes Macroeconomic Indexing for Healthcare as LDP Talks Resume
March 24, 2026
- Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
March 24, 2026
- MHLW Panel Calls for Careful Design of OTC-Like Drug Charge System
March 23, 2026
- Japan Hands Out Orphan Tags to Ianalumab, Bleximenib, and Lots More Drugs
March 23, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…