Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Issues Guidance on Clinical Trial Design for Radiopharmaceuticals
Japan’s Ministry of Health, Labor and Welfare (MHLW) has issued new guidance to support the design of clinical trials for therapeutic radiopharmaceuticals, aiming to accelerate development while ensuring the safety of study participants. The guidance, titled “guideline on nonclinical studies…
To read the full story
REGULATORY
- Finance Minister Backs Further Debate on Low-Risk Medicines: CEFP Minutes
May 29, 2026
- LDP HQ Finalizes Recommendations ahead of Growth Strategy
May 29, 2026
- Japan Eyes Broader Healthcare Measures Addressing Sex-Based Health Issues
May 28, 2026
- MHLW Panel Deems 4 More “Drug Loss” Products as High-Need
May 27, 2026
- LDP Panel OKs Immunization Act Bill Aimed at Beyfortus NIP Use
May 27, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…