Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
ICH Adopts E8, M8 Guidelines; 3 Topics Reach Step 2
The International Council for Harmonization's (ICH) two guidelines reached Step 4 (adoption of ICH harmonized guidelines) at its assembly held virtually on November 15-18, while three topics reached Step 2. Step 4 was reached for the revision on the ICH…
To read the full story
REGULATORY
- Pharma Seeks Inflation-Liked Price Hikes, Freeze on Patent-Period Cuts for 2027 Revision
August 27, 2026
- Kisunla Braced for NHI Price Cut after CEA; Leqembi Method to Apply
August 27, 2026
- Xcopri, Leqembi SC Now in Line for Japan Approval with Panel Backing
August 27, 2026
- Japan Expects Flu Vaccine Supply of 51.9 Million Doses for 2026-27
August 27, 2026
- MHLW Lifts Olanzapine Diabetes Contraindication for Antiemetic Use
August 26, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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,…
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…