REGULATORY

MHLW to Draft New Guidance on Companion Diagnostics by End of 2013: Director Sato of ELD

August 20, 2013
Takeyuki Sato, director of the Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division (ELD), told reporters from trade publications on August 16 that the Ministry of Health, Labor and Welfare (MHLW) plans to draft a new operational guidance on…

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REGULATORY

By Ken Yoshino

Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…

By Takashi Ebisawa

Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…

By Philip Carrigan

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…

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By Ken Yoshino

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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…