Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Sakigake Review System to Shorten Review Time through Greater Efficiency, Not Simplification: Mr Kono of PMDA
The sakigake fast-track review system is designed to shorten the review period while ensuring that efficacy and safety are properly and efficiently evaluated, and regulators won’t skip necessary processes to shed the review time, an official of the Pharmaceuticals and…
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REGULATORY
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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…