REGULATORY

Gov’t to Discuss Expansion of Japan-EC Mutual Recognition Agreement in Pharmaceutical Sector

July 12, 2012
The government approved a regulatory reform plan that calls for an increase in the range of countries and products subject to the Japan-EC Mutual Recognition Agreement (MRA) at a Cabinet meeting on July 10. The MRA provides for mutual acceptance…

To read the full story

REGULATORY

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Shinya Sato

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

By Philip Carrigan

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,…

By Ken Yoshino

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…