Regulations for Registration of Medicinal Products Article 46
Applications for Post-approval change should be conducted in compliance with the following regulations:1.Definitions of major changes and minor changes are as announced by the central health competent authority.2.The following information should be provided for changes in manufacturing of drugs:(1) For major changes: BE study reports should be submitted;(2) For minor changes: a drug dissolution profile comparisons should be submitted.3. The following information should be provided for changes of the manufacturing site of drugs:(1) A comparison between the formula and the manufacturing process, including the sources of raw materials, specifications and manufacturing equipment;(2) A drug dissolution profile comparison;(3) If it is determined that a major change is occurred or the data is insufficient to determine a minor change, a BE study report should be submitted.4. If the application of post-approval changes involves multiple changes in the formula and manufacturing processes, it shall be followed in accordance with its respective scope of change.5. BE studies can be substituted by BA studies along with clinical trial reports.6. BA/ BE studies should be conducted in compliance with the Regulations of Bioavailability and Bioequivalence Studies.7.Post-approval changes involve the bioavailability and bioequivalence test, the waiver or replacement of the test can follow Article 8 of the Regulations of Bioavailability and Bioequivalence Studies, or contents approved or relevant regulations promulgated by central competent health authority.For drugs already approved on the market, if the manufacturer, of their own accord, conducts a BE study and the report has been approved by the central competent health authority, and subsequent changes involved in the manufacture and manufacturing sites are subject to the regulations in the preceding paragraph.Unless otherwise provided, the requirement for the bioequivalence study or the bioavailability and clinical study report may be waived for drug products that category in the Guidelines on the Review of Over-the-counter Drugs or in the category of the preparations of inherited formulation.
中文原文 藥品查驗登記審查準則第46條
申請變更登記之藥品，其辦理之規定如下：
一、主要改變及次要改變之定義，依中央衛生主管機關公告事項規定認定之。
二、製劑如涉及製造變更者，應檢附資料如下：
（一）屬主要改變者，應檢附生體相等性試驗報告。
（二）屬次要改變者，應檢附溶離率曲線比對報告。
三、製劑如涉及製造場所變更者，應檢附資料如下：
（一）配方與製程比對，包括原料來源、規格及製造設備。
（二）溶離率曲線比對資料。
（三）如經判定屬主要改變或資料不足者，應另檢送生體相等性試驗報告。
四、申請變更之藥品，如涉及配方與製程之多重改變者，依其各別之變更範圍辦理。
五、所有生體相等性試驗，均得以生體可用率連同臨床試驗報告替代之。
六、執行之生體可用率及生體相等性試驗，應符合藥品生體可用率及生體相等性試驗作業準則之規定。
七、變更申請涉及生體可用率及生體相等性試驗者，其試驗之免除或替代，依藥品生體可用率及生體相等性試驗作業準則第八條規定、中央衛生主管機關公告或核定之內容辦理。
已核准上市之藥品，廠商自行申請執行生體相等性試驗並其報告經中央衛生主管機關審核通過，如其後涉及製造與其場所之變更者，準用前項規定。
符合指示藥品審查基準之製劑或屬成藥製劑者，除另有規定外，其變更得免附生體相等性試驗，或生體可用率與臨床試驗報告。
一、主要改變及次要改變之定義，依中央衛生主管機關公告事項規定認定之。
二、製劑如涉及製造變更者，應檢附資料如下：
（一）屬主要改變者，應檢附生體相等性試驗報告。
（二）屬次要改變者，應檢附溶離率曲線比對報告。
三、製劑如涉及製造場所變更者，應檢附資料如下：
（一）配方與製程比對，包括原料來源、規格及製造設備。
（二）溶離率曲線比對資料。
（三）如經判定屬主要改變或資料不足者，應另檢送生體相等性試驗報告。
四、申請變更之藥品，如涉及配方與製程之多重改變者，依其各別之變更範圍辦理。
五、所有生體相等性試驗，均得以生體可用率連同臨床試驗報告替代之。
六、執行之生體可用率及生體相等性試驗，應符合藥品生體可用率及生體相等性試驗作業準則之規定。
七、變更申請涉及生體可用率及生體相等性試驗者，其試驗之免除或替代，依藥品生體可用率及生體相等性試驗作業準則第八條規定、中央衛生主管機關公告或核定之內容辦理。
已核准上市之藥品，廠商自行申請執行生體相等性試驗並其報告經中央衛生主管機關審核通過，如其後涉及製造與其場所之變更者，準用前項規定。
符合指示藥品審查基準之製劑或屬成藥製劑者，除另有規定外，其變更得免附生體相等性試驗，或生體可用率與臨床試驗報告。