Pharmaceutical Good Manufacturing Practice Regulations Article 57
Chinese herbal medicine factories shall determine suitable expiration dates for Chinese herbal medicine for use in clinical trials based on the product properties, container characteristics and storage conditions; the expiration dates marked on aforesaid Chinese herbal medicine may not exceed the expiration dates marked on the original product packaging.Where clinical trials do not provide stability testing information, the usage period of a repackaged product may not exceed 25% of the remaining portion of the usage period of the original bulk product, or the six-month period following repackaging, whichever period is shorter.
中文原文 藥物優良製造準則第57條
中藥廠對於臨床試驗用藥，應依產品性質、容器特性及儲存條件，決定標籤上適當之保存期限；其標示之有效期間，不得超過原包裝產品原標示之有效期間。
臨床試驗中無安定性相關試驗資料者，再包裝產品之有效期間，不得超過原製造大宗產品所剩餘有效期間之百分之二十五，或不得超過產品經再包裝後六個月，二者以期間較短者為準。
臨床試驗中無安定性相關試驗資料者，再包裝產品之有效期間，不得超過原製造大宗產品所剩餘有效期間之百分之二十五，或不得超過產品經再包裝後六個月，二者以期間較短者為準。