Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
ORGANIZATION
Create NDA Category Modeled after FDA’s “505(b)(2)” Pathway: JEMA
The Japan Established Medicine Association (JEMA) is calling for the creation of a new regulatory application category for “improved drugs” in Japan, which would correspond to the “505(b)(2)” approval pathway that is already in place in the US. According to…
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