背景:各地區、區域及教學醫院相繼成立核子醫學科目前約有48家;其中設有醫用迴旋加速器及正子放射化學製藥設施的正子斷層造影中心約有9家醫院，可合法供應正子斷層掃描所需之核醫藥物，核子醫學影像技術正式進入正子斷層掃描之領域。本文針對國內發展「核醫藥物轉譯實驗室」的現行法規進行探討。過程:以衛生署公告之「藥事法」、「藥事法施行細則」與「藥師法」等為主要的參考法規，以釐清「正子中心」發展「轉譯實驗室」可行性的現行法規規定。結論:規劃出現代化核醫「轉譯實驗室」應符合關於人員、設備與設施等衛生法規的基本要求，以提昇核醫醫療及學術研究品質的方向不斷進步。

InTaiwan， 48 hospitals have radio-pharmacy， not only at teaching hospitals but also at local hospitals. In addition， 9 PET centers have baby cyclotrons for compounding radiopharmaceuticals. Compounding radiopharmaceuticals is common pharmaceutical practice regulated by government. Incomply with the regulations of DOH (Dep紅包lentof Health)， we proposed the basic requirements of p位sonnel， equipments and facilities of Translation Medicine Laboratory in PET center. According to this regulations， to con仕ibute祖d promote也e wellbeing of translation medicine in nuclear medicine field.