Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Submission of CDISC-Based Clinical Data Required from October 2016: Notification
The Ministry of Health, Labor and Welfare issued a notification on April 27, which specified that the ministry will require drug makers to submit electronic clinical trial data based on CDISC standards, beginning with products filed for marketing approval on…
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REGULATORY
- Japan Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
August 25, 2026
- Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
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- Japan Grants Orphan Tags to Rogocekib, Gildeuretinol, and More
August 25, 2026
- Japan Extends Re-Examination Period for Uplizna
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- 4 Drug Makers Seek Govt Aid to Upgrade Aging Plants: LDP Hearing
August 24, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…