REGULATORY
Novartis Fails to Report Nearly 5,500 Side Effect Cases, Biz Improvement Order Likely This Month
Novartis Pharma failed to report nearly 5,500 side effect cases in a legally required timeframe owing to a system glitch, likely invoking the health ministry’s business improvement order by the end of the month, sources familiar with the matter told…
To read the full story
Related Article
- Novartis Japan Told to Improve Business over Delayed Reporting of Nearly 5,500 ADRs
November 16, 2015
- Business Improvement Order Issued to Novartis Japan
November 13, 2015
- MHLW Weighs Another Business Improvement Order to Novartis
November 4, 2015
- Novartis Slapped with 15 Day Biz Suspension over Flawed ADR Reporting
February 27, 2015
- Improvement Order Issued to Novartis over Delayed ADR Reporting
August 1, 2014
REGULATORY
- Japan Govt Council Discusses Draft Recommendations for National MCM Strategy
December 9, 2025
- MHLW Eyes Govt-Led Ingredient Lists for Regional Formularies: LDP Briefing
December 9, 2025
- JMA Pushes Back on Incentives Tied to Regional Formularies: Chuikyo
December 9, 2025
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
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…





