Regulations for Registration of Medicinal Products Article 96
A manufacturer may, in one month, submit two applications for the registration of compound preparations, or six applications for single ingredient preparations, or one application for compound preparations plus three applications for single ingredient preparations, unless the manufacturer has applied to the central health competent authority for special approval by giving reasons and providing relevant data.The relevant data set forth in the preceding paragraph shall include information on the equipment and technical professionals of the drug manufacturing and quality control departments and other relevant information. When necessary, the central health competent authority may assign personnel to conduct on-site inspections of the quality control, production records, sample manufacturing processes and on-site supervision.Each application for special approval, as set forth in Paragraph 1, shall involve up to 24 cases.
中文原文 藥品查驗登記審查準則第96條
藥商在同一月內，得申請查驗登記複方二件或單方六件，或複方一件及單方三件。
但藥商敘明理由，檢附有關資料，向中央衛生主管機關專案申請核准者，不在此限。
前項有關資料，包括藥品製造、品質管制部門之設備、專業技術人員及其他相關資料。
中央衛生主管機關必要時得派員實地檢查其品質管制、生產紀錄、樣品製造過程及藥品監製者駐廠情形。
第一項專案申請，每次以二十四件為限。
但藥商敘明理由，檢附有關資料，向中央衛生主管機關專案申請核准者，不在此限。
前項有關資料，包括藥品製造、品質管制部門之設備、專業技術人員及其他相關資料。
中央衛生主管機關必要時得派員實地檢查其品質管制、生產紀錄、樣品製造過程及藥品監製者駐廠情形。
第一項專案申請，每次以二十四件為限。