REGULATORY

Evaluation of Efficacy Was Challenging in Sakigake Pick, Designating All Qualified Drugs Desirable: MHLW Official

November 27, 2015
Japanese regulators were scratching their heads when evaluating whether a drug had an outstanding efficacy compared to similar medicines on the market during the selection of products for the sakigake fast-track review system, a health ministry official revealed on November…

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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…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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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…