Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Orders Large-Scale Carcinogen Risk Inspections, Covering Almost All Drugs
The Ministry of Health, Labor and Welfare (MHLW) on October 8 issued a notification ordering pharmaceutical manufacturers to conduct self-inspections on the risk of cancer-causing nitrosamine impurities in their products. An official says that the measure covers “almost all drugs”…
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
- Carcinogen Self-Inspection Survey Suggest 10% of Products at Risk: MHLW
April 22, 2024
- Japan Weighs Adoption of EMA Approach for Nitrosamine Impurities Risk Assessment
July 14, 2023
- Sumitomo to Urge Switch from Noritren over Carcinogen Risks, but Continues Shipments
June 8, 2023
- Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
September 1, 2022
- Pharma Industry Frets Cost and Deadline of MHLW-Ordered Carcinogen Risk Inspections
February 7, 2022
- Pfizer Japan Recalling Some Champix Products after Detecting Carcinogen
July 29, 2021
REGULATORY
- Japan to Ease Olanzapine Diabetes Contraindication for Antiemetic Use
July 31, 2026
- Pipe Damage Causes Water Leak at Sawai Plant after Quake: MHLW
July 30, 2026
- MHLW Urges Stable Supply of Drugs after Kumamoto Earthquake
July 30, 2026
- Kumamoto Quake Hits 46 Medical Facilities; No Pharma Damage Yet: MHLW
July 29, 2026
- Japan Shifts Mo-99 Supply Strategy toward Stronger Global Procurement: Panel
July 29, 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…