107年度疫苗與類毒素檢驗放行案件分析   全文下載

Annual Surveillance of Batch Release: Vaccines and Toxoids in Taiwan, 2018

本研究報告統計分析食品藥物管理署（下稱食藥署）107年度經檢驗合格放行之疫苗與類毒素，以瞭解國人使用之疫苗與類毒素整體概況。107年度食藥署共放行271批次13,433,053劑疫苗與類毒素，其中國產69批次4,923,435劑，批次及劑數各佔25.5及36.7％，國外輸入202批次8,509,618劑，批次及劑數各佔74.5及63.3％；期間食藥署共攔阻3批外觀異常之流感疫苗及1批運送溫度紀錄不符規定之疫苗，4批疫苗皆不予封緘放行，並依據藥事法施行細則第36條規定，令業者限期退運或銷毀。若依疫苗及類毒素類別進行分析統計，放行批次數前3名依序為流感疫苗、日本腦炎疫苗及破傷風疫苗，放行劑數前3名依序為流感疫苗、破傷風疫苗及日本腦炎疫苗。

This report summarized the statistical analysis of the batch release of imported and domestic vaccines and toxoids by the TFDA in 2018. Two hundred and seventy-one batches of vaccines (13,433,053 doses) were released in Taiwan in 2018. The batches and doses of domestic products accounts for 25.5% (69 batches) and 36.7 % (4,923,435 doses), respectively, while those of imported products were 74.5 % (202 batches) and 63.3 % (8,509,618 doses), respectively. TFDA rejected 3 batches of influenza vaccine with abnormal appearance and 1 batch of vaccine transported under temperature being out of approved range. All of them were not allowed to release and needed to be returned or destroyed within a specified period by the original importer or manufacturer in accordance with Article 36 of Pharmaceutical Affairs Act Enforcement Rules. In terms of the number of batches released, the top three were influenza vaccine, Japanese encephalitis vaccine and tetanus toxoid. As to the number of doses released, the top three were influenza vaccine, tetanus toxoid and Japanese encephalitis vaccine.