109-111年度血液製劑檢驗封緘案件分析   全文下載

Report on Batch Release of Blood Products in Taiwan, 2020-2022

本報告為係針對109-111年度執行血液製劑檢驗封緘案件之統計分析，以瞭解國人使用血液製劑的品質總體概況，同時確認血液製劑的品質均符合中華藥典或原廠之規範。109-111年度受理具許可證之人用血液製劑檢驗封緘產品共452批，總計4,248,278瓶/組。經逐批審查與檢驗，結果均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白蛋白注射劑、免疫球蛋白注射劑、凝血因子注射劑、纖維蛋白止血組及其他等5大類產品。統計109-111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，其次為免疫球蛋白注射劑及纖維蛋白止血組。在國血製劑方面，包括血清白蛋白注射劑、免疫球蛋白注射劑、第八凝血因子、第九凝血因子等產品係委託國外血漿工廠以高標準製程製造，透過統計分析與探討，其近3年血清白蛋白注射劑、免疫球蛋白注射劑、第八凝血因子之檢驗封緘數量111年度皆為最高，然其產量尚未完全滿足需求，仍需積極給予國內血液製劑產業提供獎勵與支持，以落實「國血國用」政策之目標。

This report presents the statistical analysis of blood products released in batches in Taiwan from 2020 to 2022. Four hundred and fifty-two batches of blood products for human used, which included a total of 4,248,278 bottle sets, were examined. All the products met the criteria in the Taiwanese Pharmacopeia or the corresponding company's specifications. These 452 batches were categorized into 31 licensed products. In summary, the top three batches and numbers of blood products were albumin, intravenous immunoglobulin and fibrin sealant kit. Furthermore, intravenous immunoglobulin, albumin, factor VIII, and factor IX, which were derived from human plasma collected from voluntary blood donors in Taiwan, were manufactured with high standards in foreign plasma factories. Through statistical analysis and review over the three years, these products have been released the most in 2022 except for factor IX. However, the supply of blood products prepared domestically is not yet sufficient. Hence, it is still necessary to provide incentives and support for the domestic blood preparation industry to implement the goal of the”Our Blood For Our People”health policy.