Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Asks 15 Makers to Investigate Ranitidine, Nizatidine for Potential Carcinogen Contamination
Japanese health regulators are following in the footsteps of its counterparts in the US and Europe to review medicines containing ranitidine for their potential contamination with a cancer-causing impurity called N-nitrosodimethylamine (NDMA). On September 17, the Ministry of Health, Labor…
To read the full story
Related Article
- Yoshindo Recalls Some Nizatidine Products over Carcinogen Risks
October 26, 2023
- Zeria’s Acinon Now Sole Nizatidine Product Being Shipped as Yoshindo Launches Recall
January 13, 2023
- All Ranitidine Tablet Drugs to Be Discontinued in Japan over Carcinogen Woes
July 5, 2021
- Drug Makers Moving to Discontinue Ranitidine/Nizatidine Products over Carcinogen Issue
February 4, 2021
- ICH’s Guidelines Helped Bring NDMA Contamination Problem to Light: NIHS Officials
January 24, 2020
- Original Maker Recalls Nizatidine over Carcinogen Risks
December 4, 2019
- Ohara Launches Class I Recall for Nizatidine over Carcinogen Risks
October 24, 2019
- Ranitidine Compensation Programs Draw Complaints from Pharmacists, Separate Billing Seen “Unrealistic”
October 17, 2019
- GSK Japan to Pull Prescribed Zantac and Compensate for Substitutes; Generic Peers Follow
October 11, 2019
- GSK Japan Ups Recall Level for Zantac to “Class I”
October 10, 2019
- All 11 Manufacturers Pull Ranitidine from Shelves, “Class I” Recalls for 9 Firms
October 4, 2019
- GSK Recalls Zantac as Preventive Measure for NDMA Carcinogenic Risk
September 30, 2019
REGULATORY
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
- Health Insurance Reform Bill Sails Through Lower House
April 30, 2026
- MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
April 28, 2026
- Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
April 28, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…