Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
PMDA to Conduct Pharmacokinetic Analysis in Pilot Study on Electronic NDA Submissions
An executive member of the Pharmaceuticals and Medical Devices Agency (PMDA) said on March 28 that the PMDA will conduct a pharmacokinetic analysis in a FY2014 pilot study on the submissions of electronic new drug applications (eNDAs). To do so,…
To read the full story
REGULATORY
- 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
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- Wholesalers Urge Price Hikes on Sub-20-Yen Drugs as Negative Margins Mount
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…