Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- CEA Review Group Debates Draft Report, Eyes August 18 Wrap-Up
August 5, 2026
- Outgoing MHLW Pharmacy Chief Eyes AI as Next Frontier for Drug Regulation
August 4, 2026
- Takeda’s Orzeyful Inches Closer to Japan Approval as 1st NT1 Drug
August 4, 2026
- MHLW Gives Fuel Priority to Drug Deliveries in Quake-Hit Kumamoto
August 4, 2026
- Unami Tapped as Japan’s New Top Finance Bureaucrat
August 3, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…