Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
All Company-Led Post-Marketing Studies Should Be Regulated by PMD Law upon Clinical Research Law Amendment: Panel
A health ministry panel on February 17 generally agreed that all drug maker-sponsored post-marketing clinical studies should be regulated by the Pharmaceuticals and Medical Devices (PMD) Law if the Clinical Research Law is amended and the concept of “sponsor” is…
To read the full story
Related Article
REGULATORY
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
- MHLW, METI Launch Joint Task Force to Safeguard Medical Supply Chains
April 1, 2026
- Japan Urges Priority Supply of Petroleum-Based Materials for Medical Devices
March 31, 2026
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 FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…