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Table 2 Expert Committee on Quality of Generic Drug Products

From: Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

Organizer

Ministry of Health, Labor, and Welfare (MHLW)

National Institute of Health Sciences (NIHS)

Pharmaceutical and Medical Devices Agency (PMDA)

Members (12–14)

Academia

Representatives from Japan Medical Association, Japan Dental Association, Japan Pharmaceutical Association

Observer Industry Associations

Japan Generic Medicines Association

Federation of Pharmaceutical Manufacturers AssociationsLiterature of Japan

Information Evaluations

Scientific reports relating to quality or clinical efficacy/safety of generic products Content of concultations received by a consultatin service counter in PMDA

Tests and Evaluations

Purity, dissolution, others

Working Group on Formulation Testing

NIHS and 10 Prefectural Institutes of Health (Aichi, Fukuoka, Hyogo, Kanagawa, Kyoto, Osaka, Saitama, Shizuoka, Toyama, Tokyo)

Specific working group

Itraconazole capsule WG, Spherical adsorbent carbon WG