Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Issue Guidance for Setting Acceptable Limit for Nitrosamines This Fall
Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to issue a guidance this autumn regarding measures to manage the risk of nitrosamine impurities in pharmaceuticals. Referring to guidance from its European and US counterparts, the regulator is expected to…
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 Issues Guidance to Thwart Distribution of Drugs with Unacceptable Nitrosamine Levels
January 10, 2025
- 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
- MHLW Launches Genomic Medicine Body GeMJ
March 30, 2026
- TNF Inhibitors, Cancer Drugs Flagged in PMDA Risk Review
March 30, 2026
- Japan Ranks 9th Among 10 in AI Analysis of EFPIA Pharma Strategy Report
March 27, 2026
- MHLW Says Trial Recruitment Info Not Deemed Advertising Under PMD Act
March 27, 2026
- AMED Warns Projects without Japan Return May Miss Startup Funding
March 26, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…