Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 10
Applicants for registration and market approval shall submit documents to the central competent authority to prove that the safety or efficacy of the new orphan medical products under application is superior to the orphan medical products already approved in accordance with the regulations of Subparagraph 2, Paragraph 1, Article 18 of the Act.
中文原文 罕見疾病防治及藥物法施行細則第10條
依本法第十八條第一項第二款規定向中央主管機關申請查驗登記者，應檢附足以證明該新申請罕見疾病藥物之安全性或有效性優於已許可之罕見疾病藥物之資料。