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我國細胞治療產品法規範初探-以美歐法規範爲借鏡

An Analysis Introducing Comparison of Domestic Cell therapeutic Product Enactments with US and EU related Laws and Regulations

摘要


儘管現代的醫學已經可以治療很多疾病,然至今日,卻仍有許多難以治療的疾病(例如心臟病、癌症或組織損傷等)尚待尋求其他更先進有效之治療方法來加以解決,對此,各醫藥先進國家正快速發展如:基因治療技術、細胞治療技術及組織工程等新興醫療技術,一方面,除要再度賦予成長逐漸滯緩之醫藥產業一股新動力外,另一方面,也要一併牽動全球生醫學(Regenerative medicine)之發展:根據研究機構Global Industry Analysts,Inc.於2010年2月所公布之一份市場研究報告中指出,至2015年時,美國幹細胞產品市場,將達到30億美金。而自美國食品藥物管理局首度核准細胞治療產品-Carticel後,至2007年底,歐盟醫藥查驗總署也核准了一項由Kiadis Pharma公司所開發之一項ATIR產品,故可推知,在各類新興治療技術正如雨後春筍般向上發展之際,各界對細胞治療技術與其所可爲全人類健康照護所帶來之利益,則似要較其他新興醫療技術有著更多的期待。回頭觀察我國,由於目前國內從事細胞治療相關產品之研發單位及業者仍在少數,可知我國此項新興醫療產業之發展,現仍處於初萌階段:不過,基於此類產品對臨床上重大疾病之治療確可產生莫大之助益,因此產、學、研各界對前開細胞治療技術與產品之開發,仍投以極高之關注。總言之,在預期日後細胞治療需求可能將大幅提昇,及完善法制環境將可提供國內有意投入此類產品開發業者一個良好產業發展空間等前提下,對國際間有關細胞治療產品法規範與相關輔助措施,則理應加以注意與了解:爰此,本文擬就管理規範較爲完善的美國與歐盟細胞治療產品規範加以介紹,進而扼要觀察我國相關法規範是否足夠支持我國相關產品與產業的發展。

並列摘要


Although, the modern medical technology can treat most diseases, however as of today, there're still many disorders difficult to be cured (for example: heart attack, cancer or tissue damages), which are looking for treatments with more advance and effective therapeutic methods. Therefore, each medical-advanced country is developing the new advanced therapeutic technologies (i.e. gene therapy, cell therapy, and tissue engineering) rapidly, which also plans to infuse a new growing energy into the medical industry where its growth is getting slower. On the other hand, it will influence the development of regenerative medicine worldwide. According to the Global Industry Analysts, Inc.'s market report which was published in Feb, 2010, the US. market value of stem cell product will reach 3 billion dollars in 2015. After the first cell therapeutic product, Carticel, had been approved by US Food and Drug Administration, the European Medicine Evaluation Agency also approved another cell therapeutic product, ATIR, which was developed by Kiadis Pharma Inc. by the end of 2007. Thus, we can foresee that all circles are giving more expectations to the cell therapeutic technology which can bring benefits in healthcare for all human kind than other advanced medical technologies. Back to observe our domestic market, as there are still fewer institutions and companies to engage in the cell therapeutic research field, it can be seen that our new advanced medical industry development is still in the early stage. However, because this kind of product can bring the great benefit for clinical significant disease treatment, therefore, all circles including industry, academic, and research institution are still highly concerning about the new cell therapeutic technology and its related products development. In summary, under a presumption with the rapid demand of cell therapy and perfecting the legal environment can provide a healthy industrial development space, it would be necessary to concern and understand the international regulation about the cell therapeutic product and other supporting measures. Therefore, we will introduce the US and EU cell therapeutic product regulations first then monitor our recent regulatory measures to identify our domestic market niche.

參考文獻


王德原,體細胞治療之沿革與推動歷程,行政院衛生署食品藥物管理局,2009 年 11 月 24 日發布,全文可見於以下網址:http://www.fda.gov.tw/itemize.aspx?itemize_sn=34&pages=0&site_content_sn=69 (最後上網日:2010/5/09)
李元鳳,細胞治療人體試驗之法規管理與國內現況,醫藥品查驗中心,2006 年 5 月,頁 1,全文請見以下網址:www.cde.org.tw/03center/write/book06/ 細胞治療人體試驗.pdf (最後上網日:2010/5/09)
核准涵全文請見以下FDA網頁:http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm171702.htm (最後上網日:2010/5/9)。
42 U.S.C.
21 CFR 1271 全文請參閱 FDA 網站:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271(最後上網日:2010/5/09)。

被引用紀錄


劉珮汶(2015)。論細胞治療產品之法律管制〔碩士論文,國立清華大學〕。華藝線上圖書館。https://doi.org/10.6843%2fNTHU.2015.00292

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