Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Drug Makers Present Cases in Which PI Trials in Japanese Could Be Omitted in Multinational Studies: PMDA Workshop
The Pharmaceuticals and Medical Devices Agency (PMDA) held a workshop on December 15 for the pharmaceutical industry on the need for PI clinical studies in Japanese subjects prior to initiating multinational clinical trials including Japanese patients. A related administrative communication…
To read the full story
REGULATORY
- Government Unveils Four-Chapter Outline for 2026 Honebuto
June 26, 2026
- LDP, Ishin Leave Chuikyo Reform to Party Negotiators after Talks Stall
June 26, 2026
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
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 leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…