Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
US FDA, EMA Hold Monthly Regulatory Working-Level Talks, with Participation of PMDA as Observer
The US FDA and the European Medicines Agency (EMA) have announced that the two parties will hold a joint conference in order to discuss pharmacovigilance topics. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Canadian regulatory authority Health…
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REGULATORY
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
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- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
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- LDP Biosimilar Group Submits Request to Finance Minister, Seeks Continued Support
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- LDP’s Patch League Urges Finance Minister to Continue Coverage, Support Prices
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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…