Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan to Allow Submissions without Japanese Data If All Requirements Met
Members of a health ministry panel on pharmaceutical regulations on February 8 broadly agreed on a proposal to allow regulatory filings without clinical study data in Japanese patients if all requirements are met, such as the completion of pivotal trials…
To read the full story
Related Article
REGULATORY
- Japan to Clarify Non-Clinical Data Waivers for Repurposed Drugs, Ease Sakigake Rules
July 24, 2026
- Share of Negative-Margin WPPs Rises to 6.9%, Wholesalers Cite Communication Gap
July 24, 2026
- MHLW Unveils Preventive Healthcare Plan Focused on Dementia, Other Areas
July 24, 2026
- MHLW Eyes Limited Charge Exemptions for OTC-Like Topical Drugs
July 24, 2026
- MHLW Panel Voices Disappointment over Efluelda Launch Delay
July 24, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…