Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
The Ministry of Health, Labor and Welfare (MHLW) has proposed stipulating in the Pharmaceuticals and Medical Devices (PMD) Act that it is possible to file for regulatory approval of drugs based on real-world clinical data alone. The proposal was made…
To read the full story
Related Article
- Japan Citizens’ Group Opposes RWD-Only Drug Submissions
December 16, 2024
- Japan Wants to Spur Regulatory Use of RWD, but Still Puts Weight on RCTs
July 10, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
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…