Transcription of 各國藥品許可證管理制度之介紹 - cde.org.tw
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各國藥品許可證管理制度之介紹 - cde.org.tw
RegMed 2014 Vol. 41 7 / 1 (1) (2) 1. (European Medicines Agency, EMA) 1234/2008/EC 5 9 EMA EMA (1) 5 5 (2) 5 5 EMA (conditional approved) EMA (1) type IA minor variations IA IAIN (a) IA 12 EMA (annual reporting system) (b) IAIN (2)
RegMed 2014 Vol. 41 7 各國藥品許可證管理制度之介紹 陳慧如/陳玲貴1 前言 綜觀主要醫藥管理先進國家在藥品許可證的展延制度和年報管理現況，每個
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