부산대학교 도서관

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.