Regulations for Registration of Medicinal Products Article 74
The testing specifications for Chinese medicine, as provided in this Chapter, are based on the Taiwan Herbal Pharmacopeia, Chinese Pharmacopoeia, or other foreign pharmacopoeias or announcements acknowledged by the central health authority. References can only be taken from the last two editions; nevertheless, the testing specifications for Chinese medicine preparation shall be based on the latest edition of the Taiwan Herbal Pharmacopeia or Chinese Pharmacopoeia.In the event that the testing specifications set forth in the preceding paragraph are not listed in the Taiwan Herbal Pharmacopoeia or Chinese Pharmacopoeia or are not covered by any other foreign pharmacopoeias or announcements acknowledged by the central health authority, manufacturers and importers shall establish the testing specifications at their own discretion based on their actual needs.
中文原文 藥品查驗登記審查準則第74條
本章所定中藥之檢驗規格，以臺灣中藥典、中華藥典或中央衛生主管機關認定之其他各國藥典或公告事項為準，藥典並以最新版本或前一版本為限，但中藥製劑之檢驗規格，以臺灣中藥典或中華藥典最新版本為準。
前項檢驗規格，臺灣中藥典、中華藥典未收載或非屬中央衛生主管機關認定之其他各國藥典或公告事項者，製造及輸入業者應視需要自行定之。
前項檢驗規格，臺灣中藥典、中華藥典未收載或非屬中央衛生主管機關認定之其他各國藥典或公告事項者，製造及輸入業者應視需要自行定之。