The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
PMRJ Introduces “RS Expert Certification System”
The Pharmaceutical and Medical Device Regulatory Science (RS) Society of Japan (PMRJ) introduced in April an “RS Expert Certification System” to evaluate the knowledge and practical abilities of personnel in the fields of pharmaceutical quality, development, and post-marketing safety measures.…
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REGULATORY
- Panel to Weigh Orphan Designation for Tecartus on December 22
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- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
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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
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
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…