The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
(Update) Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
Fukuoka and Osaka prefectural authorities on December 22 issued administrative penalties to generic giant Sawai Pharmaceutical over falsifications found in its quality testing for the gastritis and gastric ulcer drug Teprenone Capsules. The authorities issued business improvement orders under the…
To read the full story
Related Article
- Sawai and Kaigen Submit Biz Improvement Plans to Osaka Govt
February 14, 2024
- JGA Issues Written Reprimand to Sawai over GMP Issues
January 30, 2024
- Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
December 22, 2023
- Sawai’s Misconduct Severely Undermines Credibility of Generics: Health Minister
October 25, 2023
- Sawai Fudged Quality Tests of Gastritis Drug for 8 Years, Awaiting Penalty Decision
October 24, 2023
- LDP Lawmakers Deplore Reported GMP Issues at Sawai
September 8, 2023
REGULATORY
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Japan, Spain Move to Deepen Pharmaceutical Regulatory Cooperation
December 23, 2025
- Japan Drops Transitional Plan for PCV20 Routine Shot in Elderly
December 23, 2025
- Tecartus Now in Line for Orphan Status with Japan Panel Nod
December 23, 2025
- LDP, Ishin Strike Deal on OTC-Like Drugs, Patients to Pay “1/4” Special Charge
December 22, 2025
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…