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頁籤選單縮合
題名 | 國內疫苗法規總論及最新沿革=The Overview and Tendency of Vaccine Regulation in Taiwan |
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作者 | 翁千惠; 謝宗穎; 蘇圯蓁; | 書刊名 | 藥學雜誌 |
卷期 | 35:1=138 2019.03[民108.03] |
頁次 | 頁154-157 |
分類號 | 418.293 |
關鍵詞 | 疫苗; 藥品查驗登記; 流感疫苗病毒株換株; Drug registration; Strain update; |
語文 | 中文(Chinese) |
中文摘要 | 根據衛生福利部疾病管制署的最新資料顯示,105年幼兒各項預防接種 (含B型肝 炎,五合一疫苗,水痘疫苗等7種常見疫苗) 完成率已高達9成。疫苗的接種已成為台 灣國人常見及接受度高的預防疾病的方式。國內也已有本土開發的數種疫苗取得藥品 許可證上市,供應公費及自費的疫苗市場。但台灣目前仍多仰賴國外輸入疫苗,故在 疫苗的藥品許可證申請及研發上會影響國內疫苗的供應。台灣衛生福利部陸續公告相 關法規以銜接國際法規,並於近年公告生物藥品得以一廠多證等新公告,試圖舒緩國 內疫苗短缺的現象。本文將綜論國內疫苗法規的發展現況,並另舉流行性疫苗年度病 毒株變更的法規要求為例,說明台灣目前疫苗法規規範。 |
英文摘要 | According to the 2016 database of Taiwan Centers for Disease Control , the completion rate of children vaccination including Hepatitis B , DTPa-IPV+Hib , Varicella vaccines and so on was up to 91%. The vaccination has obviously become one common and acceptable way to prevent diseases in Taiwan. In addition, there are several vaccines manufactured in Taiwan. However, we still rely on the imported vaccine for Tawian’s vaccination. Therefore, the vaccine regulation is so important to impact the vaccine supply to Taiwan. Taiwan FDA has published several regulation to catch up the regulation worldwide in the past years. This article will introduce the vaccine regulation in Taiwan and also indicate the latest regulation of strain update of influenza vaccine. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。