Regulations for Medicament Contract Manufacture and Analysis Article 12
An entity that conforms with any of the following descriptions may accept a contract for analysis of drug (medicinal) products:1. A medicinal product factory that is in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.2. A domestic or foreign academic research institute that meets the requirements of good laboratory practices for non-clinical laboratory studies.3. An analysis institution or laboratory that meets the certification requirements under Article 104-4 of the Act.4. Other entity approved on an ad-hoc basis by the competent central health authority.
中文原文 藥物委託製造及檢驗作業準則第12條
符合下列規定之一者，得接受委託檢驗藥物：
一、符合藥物優良製造準則之藥物製造工廠。
二、符合非臨床試驗優良操作規範規定之國內外學術研究機構。
三、符合依本法第一百零四條之四認證之檢驗機構或實驗室。
四、其他經中央衛生主管機關專案核准者。
一、符合藥物優良製造準則之藥物製造工廠。
二、符合非臨床試驗優良操作規範規定之國內外學術研究機構。
三、符合依本法第一百零四條之四認證之檢驗機構或實驗室。
四、其他經中央衛生主管機關專案核准者。