Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
With Only 5 Months Until Nitrosamine Self-Inspection Deadline, Many Challenges Remain
Only five months remain until the final deadline for large-scale self-inspections of nitrosamine impurities in pharmaceuticals that have been requested by the Ministry of Health, Labor and Welfare (MHLW). The recently released results of an MHLW survey reveal that drug…
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
- 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
COMMENTARY
- 9 Drugs Top 100 Billion Yen in FY2025 Japan Sales; Keytruda Retains Crown: Jiho Tally
August 20, 2026
- Signs of Shift in Japan’s Drug Policy, but Cost Pressures Persist
August 3, 2026
- Rare Cancer Case Raises New Questions about AAV Gene Therapy Safety
July 27, 2026
- A Turning Point for Pharma? Chuikyo Reform Could Open Door to Greater Industry Role
July 13, 2026
- DORA Use Could Expand as Japan Opens Door to “Sleep Disorders” Specialty
July 6, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
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.…
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…