Pharmaceutical Affairs Act Article 7
The term “new drugs” as used in this Act shall refer to drugs that are pharmaceutical preparations that have new molecular entities, new combinations, new indications, and a new route of administration as verified and recognized by the central competent health authority.
中文原文 藥事法第7條
本法所稱新藥，係指經中央衛生主管機關審查認定屬新成分、新療效複方或新使用途徑製劑之藥品。