| 中文摘要 |
本報告為食品藥物管理署（以下稱食藥署）106年度受理血液製劑檢驗放行案件之統計分析，以呈現國內使用之血液製劑概況。106年度食藥署共放行血液製劑152批1,253,072瓶（或組），其品質均符合中華藥典或原廠規範。分析血液製劑之放行量，血清白蛋白佔所有血液製劑放行量88.29％最多，免疫球蛋白靜脈注射劑為3.98％居次，放行之血清白蛋白以美國製造為主，免疫球蛋白靜脈注射劑則以臺灣血液基金會委託製造之國人血漿免疫球蛋白靜脈注射劑佔89％最高。
This report presents statistical results from the batch release of blood products in Taiwan in 2017. TFDA released 152 batches blood products in 2017 including 1,253,072 bottles or sets. The quality of all the released blood products complied with the specifications listed in the Chinese Pharmacopeia or that of the manufactures. According to the statistics, human albumin and intravenous immunoglobulin (IVIG) accounted for 88.29% and 7.37% of the blood products released, respectively. The human albumin was mainly imported from the United States, and 89% of the IVIG products was prepared from human plasma obtained from voluntary blood donors in Taiwan. |
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