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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