Regulations for Registration of Medicinal Products｜第 75 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
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.