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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)
RegMed 2014 Vol. 41 8 內容與收費標準而定。 2. 美國 (U.S. Food and Drug Administration, USFDA) 依據美國法規 section 506A of the Federal Food, Drug, and Cosmetic Act (the
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