管制科學與細胞治療治理：如何促進台灣獲得安全有效的細胞治療

Taipei Medical University Institutional Repository > 藥學院 > 生技醫療產業研發博士學位學程 > 博碩士論文 > Item 987654321/60479

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Title:	管制科學與細胞治療治理：如何促進台灣獲得安全有效的細胞治療 Regulatory Science and Cell Therapy Governance:How to facilitate the access to safe and effective cell therapy in Taiwan
Authors:	蔡鐙墴 TSAI, TENG-HUANG
Contributors:	新藥研發產業博士學位學程李崇僖
Keywords:	細胞治療;細胞治療管制;管制科學 Cell therapy;Regulations;Regulatory Science
Date:	2021-01-13
Issue Date:	2021-03-10 10:54:07 (UTC+8)
Abstract:	近年來幹細胞治療、免疫細胞治療和基因編輯等基礎理論、技術手段和臨床醫療探索研究的不斷發展，再生醫療（Regenerative Medicines）為一些嚴重及難治性疾病提供了新的治療思路與方法。運用細胞進行治療（Cell-based Therapies）是目前再生醫學的主要方式，而這些新的醫療技術帶給病人新曙光。由於細胞治療產品之特異性及複雜性，使得細胞治療產品的審查，有異於其他藥品審查要求。各國針對如何規範管制細胞治療產品也提出各種法規方案。目前各國對於細胞治療技術規範雖有差異，不過普遍將細胞治療依風險等級進行劃分管理，且均設有專責單位負責相關業務，可以就個別細胞產品特性、生產製程到臨床應用層面進行審查。細胞治療乃屬於新興醫療技術領域，各項技術之成效需累積相關臨床實證數據，並分析細胞輸入體內後的生物分佈情形 (Biodistribution) 及潛在風險，例如致瘤性 (tumorigenic potential)，並持續蒐集細胞治療的製程、成效與風險資訊，以確保提供安全且有效之細胞治療給民眾。為完善台灣再生醫療法制、促進醫療科技發展以及病患權益，本研究已蒐集各國法規單位之細胞治療管理現狀，分析台灣特管辦法整體法規建置脈絡，未來將以管制科學 (Regulatory Science) 概念為基礎提出管制建議，進而創造良好的投資環境，使台灣可在國際細胞療法領域中佔有一席之地。 Recognizing the potential inconsistence of cellular therapy and current medical regulatory practice, there are differences in governing cell therapy in various countries. Cell therapy is generally divided into risk management, and each department has a dedicated unit responsible for related business. Each cell therapy technology requires the relevant clinical data, and analysis of the biodistribution and potential risks for cell injection, such as tumorigenic potential. Therefore, a variety of cell therapy technology databases (biobanks) should be established and continue to collect information on the manufacture, efficacy, and risk of cell therapy to ensure safe and effective for the patient. This study has collected the current status of cell therapy regulations by regulatory agencies in various countries, analyzed the overall regulatory framework of Taiwan's special regulation for cell therapy, and will propose regulatory recommendations based on the concept of regulatory science in the future. Therefore, Taiwan will have the opportunity to advance the development of such new medical technology. This study integrates the relevant regulatory information and analyzes the current situation of technology transfer and clinical trials to create a bridge for multi-directional communication, which will help to promote the development of regulations in cell therapy in Taiwan, creating a friendlier environment for researchers, companies, and investors.
Description:	博士指導教授:李崇僖委員:黃彥華委員:林泰元委員:林仲彥委員:何建志
Data Type:	thesis
Appears in Collections:	[生技醫療產業研發博士學位學程] 博碩士論文

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