Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
“Zero Risk” of Tumorigenicity from Products Using iPS Cells Cannot Be Guaranteed at Present: PMDA’s Science Board
The Pharmaceuticals and Medical Devices Agency’s (PMDA) Science Board presented a final report of its views on the tumorigenicity of cell- and tissue-based products, including those derived from iPS cells, on August 20. The report takes into account the latest…
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REGULATORY
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
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April 16, 2026
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April 15, 2026
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…