國內醫院調製正子掃描造影藥物管理法規回顧與展望

Review and Outlook for the Regulation of Radiotracers-used in Positron Emission Tomography in Local Hospitals

正子放射斷層掃描造影（PET）為全球成長最為迅速的醫學影像技術之一。迄今國內總計41家醫療院所設置45部臨床PET掃描設備，所使用的正子掃描造影藥物絕大多數由國內9家醫院設置的迴旋加速器設施調製供應。主管機關依據「斷層掃描用正子放射同位素調製作業要點」透過現場查核規範這些醫院調製正子掃描造影藥物的做為與品質。從92年至今，總計對9家設置迴旋加速器的醫院執行95項次查核（包括32項次新品項查核及63項次後續查核）。結果查核顯示國內醫院執行正子放射同位素調製作業已符合該要點。對於國內醫界使用正子斷層掃描技術服務國人健康更能提供安全品質與保障。

Positron emission tomography (PET) is one of the world's most rapidly advancing medical imaging technology. There are currently 45 clinical PET scanners installed in 41 hospitals in Taiwan. The radiotracers used in the PET scans are mainly produced and supplied by cyclotron facilities in 9 hospitals island wide. In accordance with the ＂Regulation for manufacturing and compounding of PET radiotracers＂, the regulatory authority supervises the manner and quality of radiotracer production by means of onsite inspection of these cyclotron facilities. To date, 95 on-site inspections have been completed for nine centers, (including 32 inspections on new radiotracers and 63 follow-up inspections of approved radiotracers). The results showed that local hospitals complied with the regulation standard of have even achieved the international standard of American PET CGMP. This indicates that the PET radiotracers used clinically in Taiwan are safe and of good quality.