Prevention of Rare Diseases and Orphan Drug Act Article 21
The central competent authority shall compile annual reports for orphan drugs that have received market approval or for which permits have been issued through ad hoc application under this Act. Said reports shall detail the amounts used, number of users, adverse reactions, and other relevant information.Pharmaceutical firms and ad hoc applicants shall provide relevant information required to compile the annual reports stipulated in the preceding Paragraph.
中文原文 罕見疾病防治及藥物法第21條
經依本法核准上市或專案申請之罕見疾病藥物，應由中央主管機關編列年報，載明其使用數量、人數、不良反應及其他相關報告等資料。
藥商及專案申請者應提供相關資料，配合前項年報之辦理。
藥商及專案申請者應提供相關資料，配合前項年報之辦理。