Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
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
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…