The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Risk Management Plans for 8 APIs Published Since April 2013; Will Be Required for Approval of New Drugs and Biosimilars Starting October 1, 2014
More than a year has passed since the introduction of drug risk management plans (RMPs) in order to assess risks from the development phase through the post-marketing phase and help ensure drug safety. RMPs for a total of eight active…
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REGULATORY
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Japan, Spain Move to Deepen Pharmaceutical Regulatory Cooperation
December 23, 2025
- Japan Drops Transitional Plan for PCV20 Routine Shot in Elderly
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- Tecartus Now in Line for Orphan Status with Japan Panel Nod
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- LDP, Ishin Strike Deal on OTC-Like Drugs, Patients to Pay “1/4” Special Charge
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Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
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…