New legal framework - Harmonisation of the data exclusivity period and addition of new periods of data exclusivity
Authorisation http://www.egagenerics.com/gen-authorisation.htm
GMP, DMF, active pharmaceutical ingredients (APIs), ドラッグマスターファイル,原薬 原料藥, generic drug, 學名藥, 仿制藥, biogeneric drug
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