Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Requests Self-Inspections for All Generic Firms; Report Due by October-End
Japan’s Ministry of Health, Labor and Welfare (MHLW) issued a notification on April 5 requesting all 172 generic drug manufacturers in the country to carry out a fresh self-inspection on whether their actual production and testing comply with authorized methods.…
To read the full story
Related Article
- FPMAJ Confirms Regulatory Compliance Actions Completed for All Generic Drug Discrepancies
July 3, 2025
- FPMAJ Reports Detailed Results of Blanket Self-Inspections for Generic Firms
January 29, 2025
- Industry Explains Scheme to Deal with New Self-Inspection Asked for All Generic Makers
March 19, 2024
- MHLW to Ask All Generic Makers in Japan to Execute Self-Inspections
March 4, 2024
REGULATORY
- Japan Mulls Target on “Social Security Burden Rate” after CEFP Call
May 25, 2026
- Ishin Deepens Debate on Healthcare Macroeconomic Indexing
May 25, 2026
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 22, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…