REGULATORY

MHLW to End Manufacturing Record Inspection for Kaketsuken’s Plasma Fraction Products

June 1, 2018
The Ministry of Health, Labor and Welfare (MHLW) will stop inspecting manufacturing records for each plasma fraction product manufactured by Kaketsuken, an exceptional inspection practice. It announced its decision at a meeting of the steering committee of the Pharmaceutical Affairs…

To read the full story

REGULATORY

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Shinya Sato

More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…

By Philip Carrigan

A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…

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…