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…
COMMENTARY
Revised PAL to Embrace “Deeper” Safety Measures, Yet Also Escape Clauses to Ease Company Burdens
The Pharmaceutical Affairs Law (PAL) will be amended and renamed the Pharmaceuticals and Medical Devices Law on November 25. The upcoming amendment traces its roots to discussions launched in 2008 by a health ministry panel to investigate drug-induced hepatitis cases,…
To read the full story
Related Article
- New Pharma Law Takes Effect to Up the Ante for Safety
November 26, 2014
COMMENTARY
- MOF Autumn Proposals Signal a Shift from Drug Pricing to Cost-Sharing Reform
November 17, 2025
- Japan’s Trading Houses Gain Ground in Pharma, Rewriting the Industry Playbook
November 10, 2025
- The Price of Stability: Who Bears Japan’s Drug Distribution Burden?
October 27, 2025
- Inside Eylea - 2: Will a Bio-AG Return after Six Years? Pricing Debate Resumes
October 7, 2025
- Inside Eylea - 1: Patent Issues Behind Differences in Biosimilar Indications for AMD and DME
October 6, 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…