Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Late-Phase Trials with Overseas Participation Pragmatic Approach for Japan-Made COVID-19 Vaccine Development: PMDA Director
Yasuhiro Araki, director of the Pharmaceuticals and Medical Devices Agency’s (PMDA) Office of Vaccines and Blood Products, expressed his understanding that the PMDA will accept applications for approval of Japan-made COVID-19 vaccines based on overseas as well as domestic data,…
To read the full story
REGULATORY
- 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 to Delist 387 Drugs from NHI Price List, Including Renivace
February 16, 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…