Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
The Ministry of Health, Labor and Welfare (MHLW) has presented a proposal to create a more efficient GMP inspection system, calling for requiring onsite checks as a rule for patented drugs and new generics prone to quality issues. The proposal,…
To read the full story
Related Article
REGULATORY
- LDP Panel Finalizes Honebuto Proposal on Preventive Care, Adds Obesity Focus
June 5, 2026
- Ex-GSK Japan Head Calls for End to "Obsolete" 14-Day Prescription Limit
June 5, 2026
- Trazenta Generic Outlook Remains Clouded as Court Upholds Treatment-Method Patents
June 4, 2026
- LDP Generic Caucus Wants Swift Disclosure of Company Indicator Ratings
June 4, 2026
- LDP Social Security Panel Pushes Greater Reward for Innovation: Honebuto Proposal
June 3, 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…