108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, 2019

本研究報告統計分析食品藥物管理署（下稱食藥署）108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。108年度食藥署共放行218批次數13,087,558劑疫苗與類毒素，其中國產46批次數4,159,810劑，批次數及劑數各佔21.1％及31.8％，國外輸入172批次數8,927,748劑，批次數及劑數各佔78.9％及68.2％；期間食藥署共攔阻2批運送溫度紀錄不符規定之疫苗，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、日本腦炎疫苗及麻疹、腮腺炎與德國麻疹三種混合疫苗，放行劑數前3名依序為流感疫苗、B型肝炎疫苗及麻疹、腮腺炎與德國麻疹三種混合疫苗。

This report summarized the statistical analysis results of the batch release of imported and domestic vaccines and toxoids by the Taiwan Food and Drug Administration (TFDA) in 2019. Two hundred and eighteen batches of vaccines (13,087,558 doses) were released in Taiwan in 2019. The batches and doses of domestic products accounts for 21.1% (46 batches) and 31.8 % (4,159,810 doses), respectively, while those of imported products accounts for 78.9 % (172 batches) and 68.2 % (8,927,748 doses), respectively. TFDA rejected 2 batch of vaccine transported under temperature out of approved range. All of these vaccines were not allowed to release and should be returned or destroyed within a specified period by the original importer or manufacturer in accordance with Article 36 of the Pharmaceutical Affairs Act Enforcement Rules. In terms of the number of batches released, the top three were Influenza vaccine, Japanese encephalitis vaccine and Measles/Mump/Rubella (MMR) vaccine. As to the number of doses released, the top three were Influenza vaccine, Hepatitis B vaccine and MMR vaccine.