REGULATORY

Experts Call for Deregulations for Orphan Support, English Dossiers to Foster Biotech Ecosystem

By Yoshinori Sagehashi January 16, 2023
Members of a Japanese health ministry expert panel on January 13 called for revisiting the current regulations around the orphan drug designation system and the handling of application dossiers written in English to fuel the development of drugs originating from…

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REGULATORY

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…

By Ken Yoshino

As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…

Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…

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

By Ken Yoshino

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…