Regenerative Medicinal Products Act｜第 21 條｜Food and Drug Administration｜Act｜In Force
衛生福利部｜v1.0
Effective Date: 2026-01-01｜Last Amended: 2024-06-19
再生醫療製劑（如細胞治療、基因治療製劑）屬高度管制品，未取得藥品許可證或附款許可即製造、輸入者，可處3萬至200萬元罰鍰。此類製劑涉及人體組織、細胞來源同意與安全性，集運或一般貿易管道均不適合自行輸入，須循醫藥專業與主管機關核准途徑。
Any of the following circumstances shall result in a fine of not less than NT$30,000 and not more than NT$2,000,000 imposed by the municipal or county (city) competent authority: 1. Failure to employ dedicated personnel with relevant qualifications and expertise as required by Paragraph 2, Article 5. 2. Manufacturing or importing regenerative medicinal products without obtaining a drug license or conditional approval in violation of Paragraph 1, Article 6. 3. Unauthorized changes to the drug license, conditional approval, original registration details, or unauthorized transfer in violation of Article 7. 4. Unauthorized manufacturing or importing of regenerative medicinal products without ensuring the eligibility of the provider in violation of Paragraph 1, Article 11. 5. Manufacturing regenerative medicinal products from tissues or cells that are not from adults with mental capacity in violation of the main text of Paragraph 1, Article 12. 6. Violation of Paragraph 2, Article 12, where written consent was not obtained prior to the acquisition of tissues or cells, or failure to comply with the provisions on the exercise of consent rights as stipulated in Paragraphs 3 to 6 of the same article. 7. Failure to inform the listed matters before obtaining consent in violation of Paragraph 1, Article 13. 8. Violation of the regulations regarding the method or procedure of notification as prescribed in Paragraph 2, Article 13. 9. Publishing recruitment advertisements by entities other than pharmaceutical companies, in violation of Paragraph 1, Article 14. 10. Violation of Paragraph 1, Article 17, in which the holder of the drug license or conditional approval has not conducted safety surveillance in accordance with the announced or approved safety surveillance plan, or the medical institution has failed to provide the required safety surveillance data. 11. Violation of the regulations on the content, submission deadlines, or surveillance period of safety surveillance reports as specified in Paragraph 3 of Article 17. 12. Failure to retain records, in violation of Paragraph 1, Article 18. 13. Violation of the regulations on the scope, method, or duration of record retention as specified in Paragraph 2 of Article 18.
有下列各款情形之一者，由直轄市、縣（市）主管機關處新臺幣三萬元以上二百萬元以下罰鍰： 一、未依第五條第二項規定，聘用具相關學歷及專門知識之專任人員。 二、違反第六條第一項規定，未取得藥品許可證或有附款許可，製造或輸入再生醫療製劑。 三、違反第七條規定，未經核准擅自變更藥品許可證、有附款許可或原查驗登記事項，或擅自移轉藥品許可證或有附款許可。 四、違反第十一條第一項規定，未確保提供者合適性，擅自製造或輸入再生醫療製劑。 五、違反第十二條第一項本文規定，非以有意思能力之成年人之組織、細胞，製造再生醫療製劑。 六、違反第十二條第二項規定，未於取得組織、細胞前獲得提供者書面同意，或未依同條第三項至第六項有關同意權行使規定辦理。 七、未依第十三條第一項規定，於取得同意前，告知該項所列事項。 八、違反第十三條第二項所定辦法中有關告知方式或程序之規定。 九、違反第十四條第一項規定，非藥商為招募廣告。 十、違反第十七條第一項規定，藥品許可證或有附款許可之所有人未依公告或核定之安全監視計畫執行，或醫療機構未提供安全監視資料。 十一、違反第十七條第三項所定辦法中有關安全監視報告內容、繳交期限或監視期間之規定。 十二、違反第十八條第一項規定，未保存資料。 十三、違反第十八條第二項所定辦法中有關保存資料之範圍、保存方式或保存期限之規定。
再生醫療製劑條例第21條：再生醫療製劑未取得許可擅自製造或輸入的處罰（3萬至200萬元）。
不可。須取得藥品許可證或附款許可，並符合提供者合適性、書面同意等嚴格規定，未經核准擅自製造或輸入可處3萬至200萬元罰鍰。