Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Eyes Evaluation Indices and Guidelines to Fuel Rollout of SaMD and Cell & Gene Therapies: Official
The Ministry of Health, Labor and Welfare (MHLW) will accelerate the commercialization of software as a medical device (SaMD) and cell and gene therapies categorized as regenerative medicine products in Japan by drawing up evaluation indices and guidelines, an official…
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Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…