Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
No Skipping of Japanese Translation for COVID-19 Vaccine Dossiers: PMDA Official
The Pharmaceuticals and Medical Devices Agency (PMDA) is taking a flexible approach to help quickly commercialize COVID-19 vaccines, but it would not approve them without the Japanese translation of application dossiers submitted to overseas regulators, the PMDA’s vaccine review chief…
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