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
- Regional Formularies Gain Ground, Raising Stakes for Drug Makers, Wholesalers
September 15, 2026
- As US Pushes Global Cost Rebalancing, Can Japan Answer with Drug Prices?
September 7, 2026
- Pharma Faces Wage Challenge in 5% Era as Industry Sustainability at Stake
September 3, 2026
- Beyond Dupixent: Next Wave of COPD Biologics Takes Shape
August 25, 2026
- 9 Drugs Top 100 Billion Yen in FY2025 Japan Sales; Keytruda Retains Crown: Jiho Tally
August 20, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…