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…
REGULATORY
ICH’s Guidelines Helped Bring NDMA Contamination Problem to Light: NIHS Officials
Voluntary recalls have continued over the last year following the detection of the carcinogen N-nitrosodimethylamine or NDMA in a number of drugs. These problems were likely to be found by the introduction of the International Council for Harmonization’s (ICH) guidelines…
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
- Causes of NDMA Contamination Scandal Still under Investigation: NIHS Division of Drugs
January 27, 2020
- Metformin Manufacturers Ordered to Test for Potential Carcinogen Contamination
December 10, 2019
- Original Maker Recalls Nizatidine over Carcinogen Risks
December 4, 2019
- Ohara Launches Class I Recall for Nizatidine over Carcinogen Risks
October 24, 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
- MHLW Asks 15 Makers to Investigate Ranitidine, Nizatidine for Potential Carcinogen Contamination
September 20, 2019
REGULATORY
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
- Ishin Urges Takaichi to Revisit OTC-Like Drug Coverage, Softens Savings Target
December 5, 2025
- JPMA Chief Presses LDP Study Group to Lock In On-Patent Prices, Scrap “Spillover” Rule
December 5, 2025
- LDP, Ishin to Continue OTC-Like Drug Talks on “Special Charge” Design
December 5, 2025
- Forxiga, Zytiga Seen Taking Biggest Hit by PMP Returns in FY2026
December 5, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…