Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Create Cross-Bureau Scheme at MHLW to Fuel Rx-to-OTC Switches: Regulatory Reform Panel
Japan should further increase prescription-to-nonprescription switches by introducing a more balanced discussion scheme that would address the excessive focus of the current set-up on safety and efficacy, the government’s Regulatory Reform Promotion Council urged on July 2. The current initiatives…
To read the full story
Related Article
REGULATORY
- 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
- MHLW Approves Towa Generics for Revolade, Vimpat
March 11, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…