再生醫療製劑條例

This provision states that the law is enacted to ensure the safety, quality, and effectiveness of regenerative medical products and to protect patient rights.

有附款許可的申請人履行附款後，可以向中央主管機關申請查驗登記；未履行附款或有重大安全疑慮時，中央主管機關可以廢止附款許可。

製造或輸入取自人體組織或細胞的再生醫療製劑前，業者必須先確認來源提供者合適，相關判定、篩選與測試辦法由中央主管機關訂定。

When human tissues or cells are obtained in-country to make regenerative medical products, the provider must usually be an adult with decision-making capacity, and written consent must be obtained before collection.

再生醫療製劑製造業者在取得同意前，必須先告知指定事項；中央主管機關並可訂定告知方式、程序及其他應遵行事項。

招募再生醫療製劑組織、細胞提供者的廣告只能由藥商製作；再生醫療製劑廣告則依藥事法關於藥品廣告的規定辦理。

招募廣告不得誇大、不實或沒有科學證據；藥商刊播前要先申請核准並提供核准文件，傳播業者不得播出未核准或不符核准內容的招募廣告。

藥商在製造或運銷再生醫療製劑前，必須先取得運銷、製造許可，並符合相關製造與運銷準則。

中央主管機關可要求再生醫療製劑的許可證或附款許可持有人依安全監視計畫監測安全性，並要求定期送交安全監視報告。

藥商和醫療機構必須保存再生醫療製劑的供應來源及流向資料。

If a regenerative medical product with a conditional permit causes an adverse reaction leading to death, disability, or serious illness, the attached Article 10(1)(3) relief measures apply; if it has a drug permit, the Drug Injury Relief Act applies.

This provision defines the competent authority by level of government.

If any listed recruitment-advertising violation occurs, the central competent authority may impose an administrative fine of NTD 30,000 to 2,000,000.

If any listed violation occurs, the local competent authority may fine the offender between NT$30,000 and NT$2,000,000.

主管機關可以就再生醫療製劑的管理事項，定期或不定期進行稽查。

本條例的施行日期由行政院決定。

This article defines “regenerative medical product” and says such products are treated as drugs under Article 6 of the Pharmaceutical Affairs Act.

This provision defines four types of regenerative medicinal products: gene therapy, cell therapy, tissue engineering, and combination products.

再生醫療製劑的販賣業者和製造業者被視為藥商；製造業者還必須由專任藥師駐廠監製，並聘用符合學歷與專業知識條件的專任人員駐廠參與製造。

藥商製造或輸入再生醫療製劑前，應先向中央主管機關申請查驗登記，並取得藥品許可證或有附款許可；有附款許可還要先經再生醫療審議會審議通過。

Approved regenerative medical products need central authority approval before certain permit or registration changes, and permit transfers must be registered.

藥品許可證屆滿前，若還要繼續製造或輸入，應在到期前三到六個月申請展延；每次展延最長五年。

The central competent authority may grant a permit for certain life-threatening or severely disabling diseases after review, with conditions, and the permit may last no more than five years.