Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority for medical products in Japan. PMDA conducts scientific review of marketing authorization application of pharmaceuticals, medical devices and regenerative medical products and monitors their post-marketing safety in collaboration with the Ministry of Health, Labour and Welfare (MHLW).

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PMDA’s Training and Capacity Building in Pharmacovigilance

  • Akiko Ogata

摘要

Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority for medical products in Japan. PMDA conducts scientific review of marketing authorization application of pharmaceuticals, medical devices and regenerative medical products and monitors their post-marketing safety in collaboration with the Ministry of Health, Labour and Welfare (MHLW).