Fee-charging Standards for Reviewing the Registration of Western Medicines Article 6
Review fees for each post-approval change and extension or reissue due to damage or loss of drug licenses are as below:1. Site change or additional active pharmaceutical ingredient manufacturer of biologic drug, or biologic drug product manufacturing site change: TWD 250,000.2. Change in new indication, new administration dosage, new category: TWD 250,000.3. Change in contract manufacturing, place of production or manufacturing-site relocation: TWD 50,000.4. Change in transfer or merger: TWD 30,000.5. Change in package inserts according to the approved insert by A10 countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden or clinical references: TWD 30,000.6. Change in new indication, new administration dosage, package inserts according to the first approval: TWD 20,000.7. Change in contract packaging or labeling place of production: TWD 30,000.8. Change in manufacturing process of product and raw material: TWD 30,000.9. Change in testing specifications, methods without using a pharmacopoeia as a reference, change of immediate packaging materials, change in excipients, change in formula: TWD 20,000.10. Change in testing specifications, methods using a pharmacopoeia as a reference: TWD 2,000.11. The first application of changes in drug categorization from prescription drug to medicines designated by physicians, pharmacists and/or assistant pharmacists, or medicines designated by physicians, pharmacists and/or assistant pharmacists to over-the-counter drugs: TWD10,000.12. Application of change in product name, testing specifications, new indication for products for export only at the counter: TWD 10,000.13. Changes other than previous 12 items: TWD 10,000.14. Reissue of the license, approved label or package insert: TWD 10,000.15. Extension of a drug license: TWD 10,000.Applications of the change listed in the Item 1 and 3 are limited to one manufacturing site per application.Applications of the change listed in Paragraph 1 are limited to one change item (except the change according to the same reason).Applications of the change listed in Paragraph 1 which include a document list, each application are limited to ten drug licenses.
中文原文 西藥查驗登記審查費收費標準第6條
辦理藥品登記事項變更及許可證展延、補發者，每件應繳納之審查費如下：
一、生物藥品變更、新增原料藥廠、生物藥品變更成品製造廠，新臺幣二十五萬元。
二、新適應症、新用法用量、新類別變更，新臺幣二十五萬元。
三、委託製造、產地、遷廠變更，新臺幣五萬元。
四、移轉、合併變更，新臺幣三萬元。
五、依十大醫藥先進國核准之仿單或文獻資料變更仿單，新臺幣三萬元。
六、依首家變更適應症、用法用量、仿單，新臺幣二萬元。
七、委託包裝、貼標，新臺幣三萬元。
八、製程變更（含製劑及原料），新臺幣三萬元。
九、非依藥典檢驗規格變更、直接包材變更、賦形劑變更、處方變更，新臺幣二萬元。
十、檢驗規格、方法依藥典變更，新臺幣二千元。
十一、首家處方藥轉類為醫師藥師藥劑生指示藥品、首家醫師藥師藥劑生指示藥品轉類為成藥，新臺幣一萬元。
十二、臨櫃辦理外銷專用藥品登記事項變更（品名、檢驗規格、適應症等），新臺幣一萬元。
十三、前十二款以外之其他變更，新臺幣一萬元。
十四、許可證、標籤或仿單核定本補發，新臺幣一萬元。
十五、藥品原核准許可證有效期間展延，新臺幣一萬元。
前項第一款、第三款之變更申請，每件以一廠次為限。
第一項變更案之申請，每案以一變更為限（同系列變更除外）。
第一項中可列清冊檢送之變更項目，每案以十張藥品許可證為限。
一、生物藥品變更、新增原料藥廠、生物藥品變更成品製造廠，新臺幣二十五萬元。
二、新適應症、新用法用量、新類別變更，新臺幣二十五萬元。
三、委託製造、產地、遷廠變更，新臺幣五萬元。
四、移轉、合併變更，新臺幣三萬元。
五、依十大醫藥先進國核准之仿單或文獻資料變更仿單，新臺幣三萬元。
六、依首家變更適應症、用法用量、仿單，新臺幣二萬元。
七、委託包裝、貼標，新臺幣三萬元。
八、製程變更（含製劑及原料），新臺幣三萬元。
九、非依藥典檢驗規格變更、直接包材變更、賦形劑變更、處方變更，新臺幣二萬元。
十、檢驗規格、方法依藥典變更，新臺幣二千元。
十一、首家處方藥轉類為醫師藥師藥劑生指示藥品、首家醫師藥師藥劑生指示藥品轉類為成藥，新臺幣一萬元。
十二、臨櫃辦理外銷專用藥品登記事項變更（品名、檢驗規格、適應症等），新臺幣一萬元。
十三、前十二款以外之其他變更，新臺幣一萬元。
十四、許可證、標籤或仿單核定本補發，新臺幣一萬元。
十五、藥品原核准許可證有效期間展延，新臺幣一萬元。
前項第一款、第三款之變更申請，每件以一廠次為限。
第一項變更案之申請，每案以一變更為限（同系列變更除外）。
第一項中可列清冊檢送之變更項目，每案以十張藥品許可證為限。