Veterinary Drugs Control Act Article 3-2
The term "new drugs" as used in this Act refers to preparations which are determined by the central competent authority with new ingredients, new combinations, new indications, new routes of administration, new pharmaceutical forms, or new method of administration and dosage.
中文原文 動物用藥品管理法第3-2條
本法所稱新藥，係指經中央主管機關審查認定屬新成分、新複方、新效能、新使用途徑、新劑型或新用法用量製劑之動物用藥品。