Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan to Allow Submissions without Japanese Data If All Requirements Met
Members of a health ministry panel on pharmaceutical regulations on February 8 broadly agreed on a proposal to allow regulatory filings without clinical study data in Japanese patients if all requirements are met, such as the completion of pivotal trials…
To read the full story
Related Article
REGULATORY
- LDP Returnees Set Sights on Social Security, Drug Policy as Special Diet Opens
February 18, 2026
- 10 Firms Win Approval for Bilanoa Generics, 2 Contenders for Fycompa
February 17, 2026
- MHLW to Brand OTC-Like Drug Cost Rule as “Partially Non-Insured Care”
February 17, 2026
- Taiyo Pharma’s Propranolol Designated as Drug for Specific Use
February 17, 2026
- Japan Grants Orphan Tag to Bayer, Incyte Drugs, and 12 Others
February 17, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…