105年度血液製劑檢驗封緘案件分析   全文下載

Annual Surveillance of Batch Release: Blood Products in Taiwan, 2016

本報告為食品藥物管理署（以下稱食藥署）105年度受理血液製劑檢驗封緘案件之統計分析，以呈現我國血液製劑之使用概況。105年度食藥署共放行血液製劑146批1,363,462瓶（或組），其品質均符合中華藥典或原廠規範。分析血液製劑之封緘量，血清白蛋白佔所有血液製劑封緘量86.61%最多，免疫球蛋白靜脈注射液為5.11%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澳洲CSL公司製造之國人血漿免疫球蛋白靜脈注射液佔96%最高，亦為落實國血國用政策之代表。"

This report presents statistical results from the batch release of blood products in Taiwan in 2016. TFDA released 146 batches blood products in 2016 including 1,363,462 bottles or sets. The quality of all the released blood products complied with the specifications listed in the Chinese Pharmacopeia or the specifications of the company. According to the statistics, human albumin and intravenous immunoglobulin (IVIG) accounted for 86.61% and 5.11% of the blood products released, respectively. The human albumin was mainly imported from the United States, and 96% of the IVIG products was prepared from human plasma obtained from voluntary blood donors in Taiwan.