Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Drug Makers Present Cases in Which PI Trials in Japanese Could Be Omitted in Multinational Studies: PMDA Workshop
The Pharmaceuticals and Medical Devices Agency (PMDA) held a workshop on December 15 for the pharmaceutical industry on the need for PI clinical studies in Japanese subjects prior to initiating multinational clinical trials including Japanese patients. A related administrative communication…
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