Pharmaceutical Affairs Act Article 57-1
Institutions or companies for the research and development of medicaments, their products shall be manufactured by factories or establishments in accordance with central competent health authority regulations.The factories or establishments referred to in the preceding paragraph shall not, concurrently, manufacture other products without authorization from the central competent health authority. Medicaments manufactured for research and development purposes by said factories or establishments shall not be used on the human body without authorization from the central competent health authority.
中文原文 藥事法第57-1條
從事藥物研發之機構或公司，其研發用藥物，應於符合中央衛生主管機關規定之工廠或場所製造。
前項工廠或場所非經中央衛生主管機關核准，不得兼製其他產品；其所製造之研發用藥物，非經中央衛生主管機關核准，不得使用於人體。
前項工廠或場所非經中央衛生主管機關核准，不得兼製其他產品；其所製造之研發用藥物，非經中央衛生主管機關核准，不得使用於人體。