Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
Expedited Review Systems Now in Place in 3 Major Markets, but How Are They Different?
Three years after the US FDA launched its Breakthrough Therapy (BT) program, Japan introduced its sakigake designation system in 2015, albeit on a trial basis, followed by the EMA’s Priority Medicines (PRIME) scheme in March this year. All three are…
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- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 2025
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…