Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Starts Seeking Drug Development Requests under New Scheme
The Ministry of Health, Labor and Welfare (MHLW) has begun inviting requests from medical societies and patient groups to develop unapproved drugs and indications under a new development request scheme, which covers medicines not approved in any country. The MHLW…
To read the full story
Related Article
- Council OKs Applications Based on Data from Public Domain for 3 Drugs Including Lidocaine
July 14, 2015
- Panel on Unapproved Drugs Weighs Revamp upon Rollout of New Development Request Scheme
January 27, 2015
- MHLW Panel OKs Tweaked Requirements for New Development Request Scheme
October 15, 2014
- MHLW Panel to Elaborate Proposed Scheme to Broaden Drug Development Requests
July 15, 2014
REGULATORY
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
- Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
- MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
- MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
- MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…