Regulations for Registration of Medicinal Products Article 79
Information filled in the “efficacy” or “indications” field on the application form for Chinese medicine registration shall comply with the following regulations:1. For those using a standard formula announced by the central health competent authority as the formulation basis, the information shall be identical to the standard formula.2. For those using a well-established publication as the formulation basis, the information shall be consistent with the contents of said publication.3. For those using a formula listed in the drug license of another drug company as the formulation basis, the information shall be consistent with that in the drug license.4. If clinical trials have been conducted, the information shall be consistent with the clinical trial reports that have been submitted for recording.
中文原文 藥品查驗登記審查準則第79條
中藥查驗登記申請書之效能或適應症欄，應符合下列規定：
一、依據中央衛生主管機關公告之基準方者，所載與基準方相符。
二、依據固有典籍者，所載與典籍相符。
三、依據其他藥商之藥品許可證所載處方者，所載與藥品許可證相符。
四、經臨床試驗者，所載與經備查之臨床試驗報告相符。
一、依據中央衛生主管機關公告之基準方者，所載與基準方相符。
二、依據固有典籍者，所載與典籍相符。
三、依據其他藥商之藥品許可證所載處方者，所載與藥品許可證相符。
四、經臨床試驗者，所載與經備查之臨床試驗報告相符。