Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Generic Makers, PMDA Exploring GMP Inspection Methods for Overseas Sites; Onsite Checks Not Possible for 2 Years
Japanese drug makers and regulatory authorities have been unable to conduct onsite inspections of overseas manufacturing facilities for two years now due to the COVID-19 pandemic. To compensate, they have tried a number of makeshifts, such as remote check-ups. Jiho…
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