REGULATORY

MHLW to Draft New Guidance on Companion Diagnostics by End of 2013: Director Sato of ELD

August 20, 2013
Takeyuki Sato, director of the Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division (ELD), told reporters from trade publications on August 16 that the Ministry of Health, Labor and Welfare (MHLW) plans to draft a new operational guidance on…

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 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.…

By Shinya Sato

Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…

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…