Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Govt to Submit PMD Law Amendment Bill in Ordinary Diet Session to Introduce Emergency Approval
The Japanese government plans to submit a total of three bills related to health, labor, and welfare in the ordinary Diet session this year, which is scheduled to convene on January 17, including one to amend the Pharmaceutical and Medical…
To read the full story
Related Article
- MHLW Panel Urges Better Application of Emergency Approval
January 16, 2023
- LDP Lawmakers Want Specific Definitions for Emergency Approval Prerequisites
January 18, 2022
- Significance and Challenges around Proposed Emergency Approval Scheme, Eyes on Diet Debate
January 17, 2022
- MHLW Finalizes Paper on Emergency Approval System, Set to Submit Bill Next Year
December 28, 2021
- Japan to Revise PMD Law to Create Emergency Approval System, Final Paper Due Out by Year-End
December 23, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Japan Panel Discusses Safety, Immunity Rules for Envisaged Emergency Approval Scheme
November 19, 2021
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…