The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan Publishes List of 203 Suspected or Confirmed Nitrosamine Impurities in Medicines
Japan’s health authorities have published a list of 203 carcinogenic nitrosamines that have been suspected or confirmed to contaminate pharmaceuticals, based on findings in Japan and overseas. The list, released by the Pharmaceuticals and Medical Devices Agency (PMDA) on August…
To read the full story
Related Article
- MHLW Calls for Ongoing Nitrosamine Risk Controls after Self-Inspections
July 24, 2025
- MHLW Issues Guidance to Thwart Distribution of Drugs with Unacceptable Nitrosamine Levels
January 10, 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
- Carcinogen Self-Inspection Survey Suggest 10% of Products at Risk: MHLW
April 22, 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 Puts CEA Expansion on Hold, Sets 6-Month “Technical Discussions”
December 26, 2025
- Gist of FY2026 Drug Pricing Reform Outline
December 26, 2025
- Chuikyo OKs FY2026 Drug Pricing Reform Outline, Scraps “Spillovers” but Adds New Follow-Up Rules
December 26, 2025
- Japan Cabinet OKs Record Social Security Spending in FY2026 Budget, 105 Billion Yen in Drug Price Cuts
December 26, 2025
- MHLW Names 77 Active Ingredients for OTC-Like Drug Charges
December 26, 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…