Regulations for Registration of Medicinal Products Article 80
Information given in the “dosage and administration” field on the application form for Chinese medicine registration shall comply with the following regulations:1. The dosage shall be proportional to the content of the original formula.2. After conversion, the daily dose of Chinese medicine in concentrated form or liquid form (for internal use) shall be equivalent to that of Chinese medicine drinks; in principle, the daily dose is divided into 2-3 doses for administration.3. Dosages for children: In principle, the dose for children between the ages of 8 and 15 is two-thirds of the dose for adults; the dose for children between the ages of 5 and 7 is half of the dose for adults; the dose for children between the ages of 2 and 4 is one-third of the dose for adults; or there shall be a label specifying that the dosage for children decreases with age.Medication for infants under the age of 2 shall be decided by physicians after diagnosis and treatment. The label on OTC drugs shall not indicate the dosage and administration for infants under the age of 2.
中文原文 藥品查驗登記審查準則第80條
中藥查驗登記申請書之用法用量欄，應符合下列規定：
一、符合原處方依據之分量比例使用。
二、濃縮劑型及內服液劑中藥之每日服用量，經換算後與一日飲片量相同，原則上分二至三次服用。
三、小兒用量：原則上八至十五歲服成人三分之二量；五至七歲服成人二分之一量；二至四歲服成人三分之一量；或標示兒童依年齡遞減。
二歲以下嬰幼兒，應由醫師診治服用，成藥不得對二歲以下嬰幼兒標示用法、用量。
一、符合原處方依據之分量比例使用。
二、濃縮劑型及內服液劑中藥之每日服用量，經換算後與一日飲片量相同，原則上分二至三次服用。
三、小兒用量：原則上八至十五歲服成人三分之二量；五至七歲服成人二分之一量；二至四歲服成人三分之一量；或標示兒童依年齡遞減。
二歲以下嬰幼兒，應由醫師診治服用，成藥不得對二歲以下嬰幼兒標示用法、用量。