Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Exemption from Bioequivalence Studies Adopted as New Topic at ICH Meeting in Lisbon; Could Affect Generics as Well
“Biowaivers” that would allow drug makers to skip conducting bioequivalence studies of oral agents if certain conditions are met was adopted as a new topic (M9) at a meeting of the International Council for Harmonization of Technical Requirements for Registration…
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REGULATORY
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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…