Pharmaceutical Affairs Act Article 31
A manufacturer engaged in the manufacturing of biological drugs for human use shall employ qualified technicians who must be a graduate of the department of medical science, pharmacy, or biology from a domestic or foreign university or college, having possessed professional knowledge with more than five-year experience in the manufacturing of microbiological and immunological drugs to conduct the manufacturing.
中文原文 藥事法第31條
從事人用生物藥品製造業者，應聘用國內外大學院校以上醫藥或生物學等系畢業，具有微生物學、免疫學藥品製造專門知識，並有五年以上製造經驗之技術人員，駐廠負責製造。