Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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GL to Assess Equivalency of Biological Products Announced
The PFSB announced the guidelines to assess the equivalency and homogeneity of biological products (biotechnology products and bio-derived products) following modifications of the production process prepared in accordance with the agreements at ICH (ICH-Q5E). These guidelines present standard methods that…
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