The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
ORGANIZATION
JEMA Proposing “Improved Drug” Category with Minimal Application Dossiers
The Japan Established Medicine Association (JEMA) is proposing the establishment of a new regulatory application category called “improved drugs” in Japan. This would make it easier for companies other than the original manufacturers to seek approval for drug products containing…
To read the full story
Related Article
- Create NDA Category Modeled after FDA’s “505(b)(2)” Pathway: JEMA
February 20, 2025
ORGANIZATION
- JGA to Create “Stable Supply Network” Membership to Expand Ramp-Up Scheme
December 18, 2025
- Pharma Groups Reiterate “No” to Broader CEA Use, Huge-Seller and Spillover Rules: Joint Statement
December 17, 2025
- Japan Medical Societies Recommend RSV Vaccination for Older Adults
December 15, 2025
- Labor Union Group Submits Request, Urges Drug Pricing Overhaul amid Inflation
December 3, 2025
- Wholesalers Urge Caution on Debating 2% Buffer without Bigger Reform Picture
November 28, 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…