| 中文摘要 |
A型肉毒桿菌毒素已廣泛應用於醫學美容及肌肉張力異常、腺體亢進與疼痛等疾病的治療，目前國內核准輸入使用的A型肉毒桿菌毒素製劑共有5種廠牌，本研究對我國100-109年肉毒桿菌毒素製劑之檢驗放行案件進行統計和分析，以了解其檢驗、審查與放行情形。在100-109年共287批次肉毒桿菌毒素製劑的申請放行案件中，衛生福利部食品藥物管理署（下稱食藥署）共執行206批次檢驗及81批次同批號審查，而全部批次依中華藥典規定之檢驗項目共執行2,177項次之檢驗或審查，結果皆符合檢驗或產品規格，故予以放行共1,777,243瓶藥品。以5年為一區間統計得知：105-109年之放行批次與數量分別較100-104年增加60.9%與39.4%，可見我國對肉毒桿菌毒素製劑之需求量明顯增加。未來，食藥署將秉持相同的檢驗與審查標準，繼續為國人使用肉毒桿菌毒素製劑的安全嚴格把關。 |
| 英文摘要 |
Botulinum toxin A (BTA) is widely used in aesthetic medicine and treatment of dystonia, hypersecretory disorders and pain. Currently, five brands of BTA are licensed for importation and pharmaceutical use in Taiwan. In this report, we analyzed the cases of batch release of BTA preparations from 2011 to 2020 in Taiwan, and presented the statistical results of product testing and document review. There was a total of 287 batches of BTA preparations applied for release, of which products were tested on 206 batches and documents were reviewed on 81 batches with the same batch numbers as previously tested batches. Totally, tests and document reviews were performed on 2,177 items. All the testing and review results met the requirements and 1,777,243 vials of BTA in total were released. The number of batches and quantity released increased 60.9% and 39.4%, respectively, from 2016 to 2020, as compared to those from 2011 to 2015. It indicated increased need of BTA in Taiwan. For long-term safety in using botulinum toxin A, the same criteria in testing and document review will be strictly adhered to in the future. |
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