Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
4 Eligibility Criteria Presented for Conditional Early Approval System
The Ministry of Health, Labor and Welfare (MHLW) on June 1 presented four criteria that would make drugs eligible for a conditional early approval system, whose introduction was agreed upon by the regulator and pharmaceutical industry leaders earlier this year.…
To read the full story
Related Article
- MHLW to Announce Data Required for Conditional Early Approval
July 12, 2017
- MHLW Mulling to Add Clinical Trial Data for Generic Labels
June 2, 2017
- 3rd Sakigake Invitation for Drugs Slated for This Autumn: MHLW
June 2, 2017
- MHLW, Pharma Industry Officials Agree on Conditional Early Approval System
January 31, 2017
REGULATORY
- Japan Panel Seeks Easing of Rules on Radiopharma Research Samples
June 16, 2026
- LDP Team Reviews Draft Industry Cluster Plans for Radiopharma, Blood Products
June 16, 2026
- DPP Calls for End to Off-Year Drug Price Cuts, Chuikyo Reform
June 15, 2026
- Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
June 12, 2026
- Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
June 12, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…