Prevention of Rare Diseases and Orphan Drug Act Article 4
The Review Committee for Rare Diseases and Orphan Drugs (hereafter referred to as the Review Committee) is charged with the following duties:1.Reviewing the designation of rare diseases, and counseling on their prevention and control;2.Reviewing the designation of orphan drugs and special nutritional foods essential for the maintenance of life;3.Reviewing the registration and market approval of orphan drugs;4.Reviewing the subsidies and research and development of orphan drugs and special nutritional foods essential for the maintenance of life;5.Reviewing and providing assistance and counseling on international medical cooperation projects for rare diseases;6.Reviewing non-orphan drugs for the treatment of specific diseases;7.Providing counseling on other matters related to rare diseases.The central competent authority shall call the Review Committee and members shall consist of representatives of government organizations, medical scholars and experts and impartial citizens; at least half of the members shall be medical scholars and experts with experience in providing clinical treatment to or care for patients with rare diseases or those conducting rare diseases research; each gender shall constitute no less than one third of the committee members.To implement the matters stipulated in the first paragraph of this article, the Review Committee shall consult advice from other scholars with relevant expertise, industry representatives or advocates of patients with rare diseases.
中文原文 罕見疾病防治及藥物法第4條
下列事項由罕見疾病及藥物審議會（以下簡稱審議會）辦理：
一、罕見疾病認定之審議及防治之諮詢。
二、罕見疾病藥物及維持生命所需之特殊營養食品認定之審議。
三、罕見疾病藥物查驗登記之審議。
四、罕見疾病藥物與維持生命所需之特殊營養食品補助及研發之審議。
五、罕見疾病國際醫療合作之審議、協助及諮詢。
六、治療特定疾病之非罕見疾病藥物之審議。
七、其他與罕見疾病有關事項之諮詢。
前項審議會由中央主管機關邀集政府機關代表、醫事學者專家及社會公正人士組成，其中委員名額，至少應有二分之一以上為具罕見疾病臨床治療、照護經驗或研究之醫事學者專家；單一性別不得少於三分之一。
審議會為辦理第一項事項，應徵詢其他相關學者專家、產業或罕見疾病病人代表之意見。
一、罕見疾病認定之審議及防治之諮詢。
二、罕見疾病藥物及維持生命所需之特殊營養食品認定之審議。
三、罕見疾病藥物查驗登記之審議。
四、罕見疾病藥物與維持生命所需之特殊營養食品補助及研發之審議。
五、罕見疾病國際醫療合作之審議、協助及諮詢。
六、治療特定疾病之非罕見疾病藥物之審議。
七、其他與罕見疾病有關事項之諮詢。
前項審議會由中央主管機關邀集政府機關代表、醫事學者專家及社會公正人士組成，其中委員名額，至少應有二分之一以上為具罕見疾病臨床治療、照護經驗或研究之醫事學者專家；單一性別不得少於三分之一。
審議會為辦理第一項事項，應徵詢其他相關學者專家、產業或罕見疾病病人代表之意見。