Pharmaceutical Good Manufacturing Practice Regulations Article 58
Where a Chinese herbal medicine factory has a Chinese herbal medicine for use in clinical trials manufactured or tested on a contract basis, aforesaid contract shall clearly state that the product in question is for use in clinical trials only.
中文原文 藥物優良製造準則第58條
中藥廠對於臨床試驗用藥委託製造及檢驗者，其委託契約，應明確規定該產品限供臨床試驗之用。