Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Exemption of Clinical Trials in Japanese Subjects Depends on Factors Such as Possibility to Infer Safety: PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) explained on November 24 its criteria for the exemption of long-term clinical trials in Japanese subjects. At a workshop held by the PMDA and industry organizations including the Japan Pharmaceutical Manufacturers Association (JPMA)…
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REGULATORY
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