Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will establish a team dedicated to reviewing cell and gene therapies designated for its sakigake fast-track pathway in FY2020 as it gears up for a flurry of approvals for these up-and-coming products. Funds…
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