Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Sets Target Duration of SaMD Priority Reviews to 6 Months in FY2024 Plan
The Pharmaceuticals and Medical Devices Agency (PMDA) has set a target of six months for the total review period of products filed under the software as a medical device (SaMD) priority review system. This plan was presented at a steering…
To read the full story
Related Article
- Panel OKs 3 Products for 1st SaMD Priority Review Designations
March 29, 2023
- Japan to Roll Out Pilot Program for SaMD Priority Review System
September 7, 2022
REGULATORY
- 874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
- Truqap Price Cut Set at 10.7% from June under CEA Scheme
March 12, 2026
- Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 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…