Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 12
When considering the reasonableness of the prices of orphan medical products, the central competent authority shall consult the price analysis information supplied by new applicants and right-holders, The National Health Insurance Pharmaceutical Benefits and Reimbursement Schedule, as well as other related information in accordance with the regulations of Subparagraph 4, 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12條
中央主管機關依本法第十八條第一項第四款規定為罕見疾病藥物售價合理與否之認定時，應參考新申請人及權利人檢送之售價分析資料、全民健康保險藥物給付項目及支付標準及其他有關資料。