108年度血液製劑檢驗封緘案件分析   全文下載

Annual Report on Batch Release of Blood Products in Taiwan, 2019

本報告係食品藥物管理署108年度執行血液製劑檢驗封緘案件之統計分析，以瞭解國人使用之血液製劑整體品質概況，並確認各血液製劑品質均能符合中華藥典或原廠之規範。108年度受理血液製劑檢驗封緘產品共168批，總計1,563,262瓶／組。經逐批審查與檢驗，結果符合中華藥典或原廠規範，合格率100％，業已核發封緘證明書並放行，以供國人用於治療或預防相關疾病。血液製劑主要可分為四大類產品，白蛋白注射劑、免疫球蛋白注射劑、凝血因子注射劑及纖維蛋白止血組。統計108年度申請檢驗封緘之批數及總數量最多者為白蛋白注射劑；在國血製劑方面，檢驗封緘數量以血清白蛋白注射劑最多，其次係免疫球蛋白。透過統計分析與探討，國人血漿所製備之血液製劑供應尚足以供國人使用，也是落實國血國用政策之目標。

This report summarizes the statistical analysis results of batch released blood products in Taiwan in 2019. One hundred and sixty-eight batches of blood products, which included a total of 1,563,262 bottles were examined. All the products complied with the specifications listed in the Chinese Pharmacopeia or the respective company's specifications. These 168 batches belonged to 31 licensed products. In summary, the top three number of batches of blood products were albumin, intravenous immunoglobulin and fibrin sealant kit, and the three highest numbers of blood products were albumin, intravenous immunoglobulin and fibrin sealant kit. In addition, 70.67% of intravenous immunoglobulin bottles, 8.16% of albumin bottles, 70.96% of factor VIII bottles, and all of factor IX bottles, were prepared from human plasma obtained from voluntary blood donors in Taiwan.