Regulations on Human Trials Article 3-1
For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical devices, or medical technologies are available in Taiwan, a medical care institution may draft a subsidiary proposal for a human cell therapy trial that has been approved by the central competent authority and has accumulated a considerable amount of safety data, and may submit the same, together with a photocopy of the original human trial proposal approved, for review in accordance with Paragraph 3 of Article 78 of this Act. After approval by the Review Board, the institution may apply to the central competent authority for approval of using the drugs, medical devices, or medical technologies involved on patients who meet the indications but fail to meet the eligibility criteria for original human trial subjects.A medical care institution may charge the specific patients set forth in the preceding paragraph fees, without being subject to the provisions of Article 11. However, the amount of fees charged shall be limited to an amount that is sufficient to cover the fees incurred by handling, manufacturing, obtaining, transporting, or storing the drugs, medical devices, or medical technologies required for performing human cell therapies on such specific patients.A medical care institution must not perform regular medical treatments under the pretense of carrying out the subsidiary proposal, and must not charge fees from specific patients in violation of the fee rules stipulated in the approved subsidiary proposal.The subsidiary proposal, as set forth in Paragraph 1, shall indicate the following:1. Reasons and purposes;2. Methods: including the conditions of the specific patient(s), recruitment method, number of persons enrolled, implementation method, duration and schedule, track and necessary rehabilitation plans;3. Possible damages and responding remedies;4. An analysis, list, and amount of the cost for the fees if fees will be charged, and the methods of providing subsidies or the amount of subsidies if subsidies are provided.The number of specific patients enrolled, as set forth in Subparagraph 2 of the preceding paragraph, shall not exceed the number of original human trial subjects.The subsidiary proposal conductor shall be the conductor of the original human trial proposal. The disclosure, review, avoidance, inspection, disposition or termination, retention, reporting, publication or promotion of the trial subject consent forms and proposals, as well as the destruction or reutilization of the data thereof, shall be subject to the applicable provisions of this Act and these Regulations.
中文原文 人體試驗管理辦法第3-1條
醫療機構為治療危及生命或嚴重失能，且國內尚無具有療效之藥品、醫療器材或醫療技術可資適用之特定病人，得就經中央主管機關核准，且累積相當安全數據之人類細胞治療人體試驗，擬訂附屬計畫，連同已核准之原人體試驗計畫影本，依本法第七十八條第三項規定審查通過後，向中央主管機關申請核准使用於符合相當適應症而未能符合原人體試驗受試者資格者。
醫療機構得向前項特定病人收取費用，不適用第十一條規定。
但其收取之費額，以足資處理、製造、取得、運送或貯存該特定病人施行人類細胞治療所需藥品、醫療器材或醫療技術之費用為限。
醫療機構不得假藉施行附屬計畫名義，施行常規醫療；亦不得違反經核准附屬計畫內所定收費規定，向特定病人收費。
第一項附屬計畫，應載明下列事項：
一、原因、目的。
二、方法：包括特定病人之條件、收納方式、人數、實施方式、期間與進度、追蹤及必要之復健計畫。
三、可能引起之損害及其救濟措施。
四、收費者，其費用之成本分析、項目及金額；有補助者，其補助方式或金額。
前項第二款特定病人之收納人數，不得超過原人體試驗受試者人數。
附屬計畫主持人為原人體試驗計畫主持人；其受試者同意書、計畫之公開、審查、迴避、查核、處分或終止、保存、通報、資料之銷毀或再利用及發表或宣傳，依本法及本辦法相關規定辦理。
醫療機構得向前項特定病人收取費用，不適用第十一條規定。
但其收取之費額，以足資處理、製造、取得、運送或貯存該特定病人施行人類細胞治療所需藥品、醫療器材或醫療技術之費用為限。
醫療機構不得假藉施行附屬計畫名義，施行常規醫療；亦不得違反經核准附屬計畫內所定收費規定，向特定病人收費。
第一項附屬計畫，應載明下列事項：
一、原因、目的。
二、方法：包括特定病人之條件、收納方式、人數、實施方式、期間與進度、追蹤及必要之復健計畫。
三、可能引起之損害及其救濟措施。
四、收費者，其費用之成本分析、項目及金額；有補助者，其補助方式或金額。
前項第二款特定病人之收納人數，不得超過原人體試驗受試者人數。
附屬計畫主持人為原人體試驗計畫主持人；其受試者同意書、計畫之公開、審查、迴避、查核、處分或終止、保存、通報、資料之銷毀或再利用及發表或宣傳，依本法及本辦法相關規定辦理。