Pharmaceutical Affairs Act Enforcement Rules Article 2
Terms used in Article 7 of the Act are defined as follows:1. New composition: a newly invented composition that can be used for pharmaceutical purposes.2. New therapeutic compound: an already approved drug with new medical efficacy in terms of new indications, reduced side effects, improved therapeutic strength, improved therapeutic period, or altered dosage, or a compound prepared from two or more already approved compositions whose medical efficacy is superior to either of the individual drug compositions.3. New method of administration: An altered method of administration for an already approved drug.
中文原文 藥事法施行細則第2條
本法第七條，用詞定義如下：
一、新成分：指新發明之成分可供藥用者。
二、新療效複方：指已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能，或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。
三、新使用途徑：指已核准藥品改變其使用途徑者。
一、新成分：指新發明之成分可供藥用者。
二、新療效複方：指已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能，或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。
三、新使用途徑：指已核准藥品改變其使用途徑者。