Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ICH Adopts E8, M8 Guidelines; 3 Topics Reach Step 2
The International Council for Harmonization's (ICH) two guidelines reached Step 4 (adoption of ICH harmonized guidelines) at its assembly held virtually on November 15-18, while three topics reached Step 2. Step 4 was reached for the revision on the ICH…
To read the full story
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…