The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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 Weighs Scrapping “Spillover” Rule in Shift from Draft Reform Outline
December 24, 2025
- Heparinoid, Allergy Drugs among OTC-Like Meds Up for Special Charge Rule
December 24, 2025
- Japan Hands Out Orphan Designation to 11 Drugs
December 24, 2025
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Japan, Spain Move to Deepen Pharmaceutical Regulatory Cooperation
December 23, 2025
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…