Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
The Ministry of Health, Labor and Welfare (MHLW) on January 25 announced a revision to its Q&As for guidance on the quality, safety, and efficacy assurance of biosimilars. With the update, the regulator now no longer requires comparability data in…
To read the full story
Related Article
REGULATORY
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
December 16, 2025
- LDP Biosimilar Group Submits Request to Finance Minister, Seeks Continued Support
December 16, 2025
- LDP’s Patch League Urges Finance Minister to Continue Coverage, Support Prices
December 16, 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…