Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
REGULATORY
MHLW to Issue Business Practice Improvement Order to Novartis for Violation of ADR Reporting Requirement
The Ministry of Health, Labor and Welfare (MHLW) plans to issue a business practice improvement order based on the Pharmaceutical Affairs Law (PAL) in late July to Novartis Pharma in response to the company’s failure to report information on adverse…
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REGULATORY
- PMDA Halts Medical Device Application Platform after Unauthorized Access
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October 30, 2026
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The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…