Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Pharma Industry Wants “Internationally Harmonized” Rules under PMD Act
The Japanese pharmaceutical industry on May 16 strongly called for creating “internationally harmonized” regulatory systems through the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. The Health Sciences Council’s (HSC) subcommittee on pharmaceuticals and medical devices regulations at…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- Council Floats 9.6% Growth Target for Japan’s On-Patent Drug Market
March 11, 2026
- MHLW Approves Towa Generics for Revolade, Vimpat
March 11, 2026
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 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…