Pharmaceutical Affairs Act｜第 48-2 條｜Food and Drug Administration｜Act｜In Force
第 四 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
本條是特定藥品專案核准製造或輸入的依據，得不受藥事法第三十九條規定之限制。適用情形有二：一、為預防、診治危及生命或嚴重失能之疾病，且國內尚無適當藥品或合適替代療法；二、因應緊急或重大影響公共衛生情事之需要。專案核准得被廢止的情形有三：已有取得許可證之藥品或合適替代療法可提供需要；緊急或重大影響公共衛生情事已終結；藥品經評估確有影響用藥安全或醫療效能疑慮。必要時並得令申請者就未使用之藥品限期處理或回收。
Under any of the following circumstances, the central competent health authority may approve the manufacture or import of specific drugs as a special case and such approval is not subject to Article 39: I. For the purpose of prevention, diagnosis, and treatment of life-threatening, severely disabling diseases, there are no appropriate drugs or alternative treatments available domestically. II. In response to the necessity of emergency or major public health circumstances. Where any of the following circumstances occur, the central competent health authority may revoke the approval granted in the preceding paragraph; if necessary, may order the applicants to handle unused drugs within a prescribed time limit, and may publicly announce the recall thereof: I. Where a drug obtains market approval for registration or an appropriate treatment becomes available corresponding to the circumstance prescribed in Subparagraph 1 of the preceding paragraph. II. Where the emergency or major public health circumstance has been terminated. III. Where the drug was reviewed and considered with concerns about its safety or medical efficacy by the central competent health authority. The application eligibility, review procedures, approval criteria, and other matters to be complied with in regard to the special approval referred to in the first paragraph shall be prescribed by the central competent health authority.
依本條第一項，有下列情形之一者，中央衛生主管機關得專案核准特定藥品之製造或輸入，不受第三十九條規定之限制：一、為預防、診治危及生命或嚴重失能之疾病，且國內尚無適當藥品或合適替代療法；二、因應緊急或重大影響公共衛生情事之需要。
依本條第二項，有下列情形之一者中央衛生主管機關得廢止核准：已有取得許可證之藥品或有合適替代療法可提供第一項第一款情事之需要；緊急或重大影響公共衛生情事已終結；藥品經中央衛生主管機關評估確有影響用藥安全或醫療效能疑慮。必要時得令申請者就未使用之藥品限期處理或回收。