Regulations for Registration of Medicinal Products Article 75
The formulation basis of Chinese medicine shall be in compliance with any of the following regulations:1. For the formulas included in the “Standard Formulas of Chinese Medicine” announced by the central health competent authority, the dosage form and formula contents shall be identical to those stated in the “Standard Formulas of Chinese Medicine”.2. The formulas conform to those listed in well-established publications or any other publications recognized by the central health competent authority.3. The formulas conform to those listed in the drug licenses held by other drug companies. However, formulas that are listed in the drug licenses issued by the Ministry of the Interior or renewed by the central health competent authority but not listed in any of the well-established publications shall not be used as the formulation basis.4. In the case of export licenses, the formulas shall be included in the importing country’s pharmacopeia or standard formulas or shall meet purchase order requirements.The well-established publications mentioned in Subparagraph 2 of the preceding paragraph refer to “Yi Zong Jin Jian (Golden Mirror of Medicine)”, “Yi Fang Ji Jie (Analytic Collection of Medical Formulas)”, “Ben Cao Gang Mu (Compendium of Materia Medica)”, “Ben Cao Gang Mu Shi Yi (Supplement to Compendium of Materia Medica)”, “Wai Ke Jheng Zhong (Orthodox Manual of External Disease)”, “Ben Cao Bei Yao (Essentials of Materia Medica)”,“Grand Dictionary of Chinese Medicine”, and “Chinese Materia Medica Grand Dictionary”.The license number or publication title, edition number, and page numbers shall be indicated in the “formulation basis” field of a registration application form. A photocopy of the formulation basis shall be submitted.The dosage form of products to be manufactured or imported shall be identical to the dosage form that is indicated in the formulation basis submitted in accordance with the preceding paragraph, except for the cases where the powder and capsule forms are interchangeable or where all forms of concentrated Chinese medicine preparations are interchangeable.
中文原文 藥品查驗登記審查準則第75條
中藥之處方依據，應符合下列規定之一：
一、屬中央衛生主管機關公告之基準方者，其劑型、處方內容，與基準方所載者相同。
二、符合固有典籍或其他經中央衛生主管機關認可之典籍所載之處方。
三、符合其他藥商藥品許可證所載之處方。
但內政部核發或其後經中央衛生主管機關換發之非屬固有典籍收載之藥品許可證所載之處方，不得為處方依據。
四、屬外銷專用許可證者，符合輸入國藥典、基準方或訂單要求。
前項第二款固有典籍，指醫宗金鑑、醫方集解、本草綱目、本草綱目拾遺、外科正宗、本草備要、中國醫學大辭典及中國藥學大辭典。
查驗登記申請書之處方依據欄，應記載許可證字號或書名、版次及頁數，並檢附其影本。
前項所檢附處方依據之劑型，應與擬製造、輸入者相符。
但散劑、膠囊劑互為變換，或中藥濃縮製劑各劑型之間互為變換者，不在此限。
一、屬中央衛生主管機關公告之基準方者，其劑型、處方內容，與基準方所載者相同。
二、符合固有典籍或其他經中央衛生主管機關認可之典籍所載之處方。
三、符合其他藥商藥品許可證所載之處方。
但內政部核發或其後經中央衛生主管機關換發之非屬固有典籍收載之藥品許可證所載之處方，不得為處方依據。
四、屬外銷專用許可證者，符合輸入國藥典、基準方或訂單要求。
前項第二款固有典籍，指醫宗金鑑、醫方集解、本草綱目、本草綱目拾遺、外科正宗、本草備要、中國醫學大辭典及中國藥學大辭典。
查驗登記申請書之處方依據欄，應記載許可證字號或書名、版次及頁數，並檢附其影本。
前項所檢附處方依據之劑型，應與擬製造、輸入者相符。
但散劑、膠囊劑互為變換，或中藥濃縮製劑各劑型之間互為變換者，不在此限。