Prevention of Rare Diseases and Orphan Drug Act Article 16
In processing applications for the registration and market approval of orphan drugs, the central competent authority may, where necessary, require the applicant to conduct domestic clinical trials. The contents of the clinical trial application process and results shall be adequately made public.
中文原文 罕見疾病防治及藥物法第16條
申請罕見疾病藥物查驗登記者，中央主管機關於必要時，得要求其進行國內臨床試驗，並應對臨床試驗之申請內容及結果予以適當之公開說明。