Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
The Ministry of Health, Labor and Welfare (MHLW) has introduced a new category of post-approval procedures for “moderate-risk” manufacturing changes for ethical drugs, which would shorten the review period from the current median six months to 40 days. The new…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
REGULATORY
- Trump Signs Off on Up to 100% Tariffs on Drugs; Japan Rate Set at 15%
April 3, 2026
- Japan Launches Task Force to Secure Critical Supplies amid Middle East Crisis
April 3, 2026
- MHLW Streamlines Lot Release Procedures for Vaccines, Blood Products
April 3, 2026
- MHLW Allows Outer Packaging Labeling for Regenerative Medicine Products
April 3, 2026
- MHLW’s Drug Supply Monitoring System Now Up and Running
April 3, 2026
Japan will overhaul its R&D tax credit regime in its FY2026 reform, introducing a new strategic category alongside existing frameworks.…
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
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…