Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
Japanese regulators should immediately green-light the pediatric use of 16 cancer drugs approved for adults in Japan that carry indications for children in the US as a special measure that goes beyond the existing laws and regulations, a clinical oncologist…
To read the full story
Related Article
- MHLW to Clarify Criteria for Japanese PI Waivers through Q&A, Calls for Data-Based Justifications
October 14, 2025
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
- PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
July 10, 2025
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- Japanese PI Waiver Good News to Mega Pharma and Emerging Players Alike: Pfizer Execs
January 21, 2025
- Japan Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
REGULATORY
- Japan Set to Compile Support Measures to Secure MCMs by Year-End
October 15, 2026
- Japan to Weigh Necessary Measures for FY2027 Revision: PM
October 15, 2026
- Japan Eyes Multi-Year Funding to Secure MCMs: Takaichi
October 14, 2026
- Pharma Continues Reform Push at 2nd Public-Private Subgroup Meeting
October 13, 2026
- AbbVie’s TrenibotE Up for Review on Oct. 26, Aquipta on Agenda Too
October 13, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…