REGULATORY

MHLW Council Recommends OTC Switch of Polycarbophil Calcium

March 19, 2019
Experts on a health ministry panel on March 14 agreed to recommend the prescription-to-nonprescription switch of polycarbophil calcium on the condition that it also be indicated for irritable bowel syndrome (IBS) and that its use be restricted to persons who…

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 Takashi Ebisawa

International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…

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…