Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Carcinogen Self-Inspection Survey Suggest 10% of Products at Risk: MHLW
Some 10% of pharmaceutical products might be at risk of being contaminated with potentially carcinogenic nitrosamine impurities, according to survey results released by the Ministry of Health, Labor and Welfare (MHLW). In October 2021, the MHLW issued a notification urging…
To read the full story
Related Article
- Japan Publishes List of 203 Suspected or Confirmed Nitrosamine Impurities in Medicines
August 6, 2025
- MHLW Calls for Ongoing Nitrosamine Risk Controls after Self-Inspections
July 24, 2025
- MHLW to Issue Guidance for Setting Acceptable Limit for Nitrosamines This Fall
August 6, 2024
- Nitrosamine Self-Inspection Deadline Extended to Aug. 1 amid Challenges
August 1, 2024
- With Only 5 Months Until Nitrosamine Self-Inspection Deadline, Many Challenges Remain
June 7, 2024
- Pharma Industry Frets Cost and Deadline of MHLW-Ordered Carcinogen Risk Inspections
February 7, 2022
- MHLW Orders Large-Scale Carcinogen Risk Inspections, Covering Almost All Drugs
October 11, 2021
REGULATORY
- Japan’s 1st Xolair Biosimilar Likely from Celltrion as JAN Is Assigned
January 23, 2026
- DPP Vows to Scrap Off-Year Drug Price Revisions in Election Platform
January 23, 2026
- Japan Starts Review on Scope of Drugs Eligible for Immunization Use, with Beyfortus in Focus
January 23, 2026
- Takeda’s Miyabashira Urges National Strategy Act to Revive Japan as Innovation Powerhouse
January 22, 2026
- LDP Pledges to Position Pharma as Core Industry in Campaign Platform
January 22, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
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…
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…