Skip to main content

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