Regulations for Registration of Medicinal Products Article 34
If more than four applications for drug registration are to be filed in the same month, the applicant should apply for an approval by giving reasons and providing information on the manufacturer, including information on the equipment and technical staffs of the manufacturing and quality control departments and the manufacturer’s actual manufacturing capacity. This information has to be confirmed by the central health competent authority through dossier review or site inspection of quality control, production records, sample manufacturing processes and on-site supervision.For manufacturers meeting the validation requirements in accordance with the schedule stipulated in Article 21 Paragraph 3, each manufacturer can file three applications for drug registration every month or 36 cases every year.
中文原文 藥品查驗登記審查準則第34條
申請人如在同一月份內申請藥品查驗登記四件以上者，應事先提出專案申請，說明理由並檢附製造廠有關資料，包括藥品製造、品質管制部門之設備及專業技術人員等資料，經中央衛生主管機關審查或派員實地檢視其品質管制、生產紀錄、樣品製造過程及藥品監製者駐廠情形，以確認其符合實際並有製造能力。
藥廠如分別依第二十一條第三款時程規定完成確效作業者，每月得申請藥品查驗登記三件或一年三十六件。
藥廠如分別依第二十一條第三款時程規定完成確效作業者，每月得申請藥品查驗登記三件或一年三十六件。