Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 8
Similar medical product mentioned in Paragraph 1 and Paragraph 2, Article 17, and Paragraph 1, Article 18 of the Act refers to the following：1.The active substance(s) and the indication(s) that are the same as the chemical drugs with previously issued permit license upon registration and market approval in accordance with this Act, including structural isomers, complex, salts, esters, chelate or other non-covalent derivatives.2.The principal molecular structural features and the indication(s) are the same as the biological or macromolecular product with previously issued permit license upon registration and market approval in accordance with this Act.
中文原文 罕見疾病防治及藥物法施行細則第8條
本法第十七條第一項、第二項及第十八條第一項所稱之同類藥物如下：
一、有效成分及適應症與依本法查驗登記發給許可證之一般化學藥物相同者，包括其結構上之異構物、錯化物、鹽類、酯類、螯合物或其他非共價鍵衍生物。
二、主分子結構及適應症與依本法查驗登記發給許可證之生物製劑或大分子藥物相同者。
一、有效成分及適應症與依本法查驗登記發給許可證之一般化學藥物相同者，包括其結構上之異構物、錯化物、鹽類、酯類、螯合物或其他非共價鍵衍生物。
二、主分子結構及適應症與依本法查驗登記發給許可證之生物製劑或大分子藥物相同者。