The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
CRO Association to Compile Guidelines for Third-Party Outsourcing after GCP Revision
The Japan CRO Association (JCROA), an umbrella body of 28 contract research organizations (CROs), will start drawing up guidelines for the outsourcing of clinical trial-related work to third parties, as they expect to see greater business opportunities following the revision…
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REGULATORY
- Panel to Weigh Orphan Designation for Tecartus on December 22
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- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
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- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
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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…