Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Ex-PMDA Inspector Urges Improvements in Japanese Inspection Systems after GMP Scandals
Japanese generic majors Kobayashi Kako and Nichi-Iko Pharmaceutical incurred administrative sanctions in February and March, respectively, due to GMP violations over the years. Why didn’t inspectors identify these problems sooner? Shingo Sakurai, a former inspector with the Pharmaceuticals and Medical…
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REGULATORY
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