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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 李素華 | zh_TW |
dc.contributor.advisor | Su-Hua Lee | en |
dc.contributor.author | 郭士馨 | zh_TW |
dc.contributor.author | Shih-Hsin Kuo | en |
dc.date.accessioned | 2024-02-22T16:35:06Z | - |
dc.date.available | 2024-02-23 | - |
dc.date.copyright | 2024-02-22 | - |
dc.date.issued | 2024 | - |
dc.date.submitted | 2024-02-01 | - |
dc.identifier.citation | BSi. A guide to the In Vitro Diagnostic Directive. Retrieved May 1, 2022, from https://www.bsigroup.com/globalassets/localfiles/en-hk/medical%20device/bsi-md-ivd-diagnostic-directive-guide-brochure-uk-en.pdf
BSi. 快速回顧:歐盟醫療器材法規IVDR核心變化. Retrieved May 1, 2022, from https://www.bsigroup.com/globalassets/localfiles/zh-tw/medical_device/document/ivdr-faq-tw.pdf COVID-19公費核酸檢驗費用撥款情形 https://www.cdc.gov.tw/Category/MPage/yuNKM3fnmrjMFbnP4yzesg EMA (2007) GUIDELINE ON DECLARATION OF STORAGE CONDITIONS: A: IN THE PRODUCT INFORMATION OF MEDICINAL PRODUCTS B: FOR ACTIVE SUBSTANCES. Retrieved Sep 6, 2023 from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-declaration-storage-conditions_en.pdf EMA. (2021) Notice to stakeholders: questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. https://health.ec.europa.eu/system/files/2023-07/guidance_regulatory_covid19_en_0.pdf EMA. Conditional marketing authorization. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation#use-during-covid-19-pandemic-section EMA. Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746). https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf EU. (2020) EU health preparedness: Recommendations for a common EU testing approach for COVID-19. Retrieved Nov 19, 2022 from https://health.ec.europa.eu/system/files/2020-09/common_testingapproach_covid-19_en_0.pdf European Commission. Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. Retrieved Sep 8, 2023 from https://health.ec.europa.eu/system/files/2021-06/covid-19_ivd-qa_en_0.pdf Fan, Y. T., et al. (2022). The requirements of nucleic acid test for COVID-19 during public health emergency: Current regulatory in Taiwan, Singapore, and the United States. Journal of the Chinese Medical Association : JCMA, 85(11), 1038–1043. Faculty of Public Health. Differences between screening and diagnostic tests and case finding. Retrieved Nov. 26, 2023 from https://www.healthknowledge.org.uk/public-health-textbook/disease-causation-diagnostic/2c-diagnosis-screening/screening-diagnostic-case-finding. FDA (2021) Antigen Diagnostic Template. Retrieved Sep 11, 2023 from https://www.fda.gov/media/137907/download?attachment FDA (2021) Molecular Diagnostic Template. Retrieved Sep 11, 2023 from https://www.fda.gov/media/135900/download?attachment FDA (2021) Serology Template. Retrieved Sep 11, 2023 from https://www.fda.gov/media/137698/download?attachment FDA (2023). COVID-19 Emergency Use Authorizations for Medical Devices. Retrieved Aug. 26, 2023 from https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/covid-19-emergency-use-authorizations-medical-devices FDA (2023). Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)—Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff. Retrieved from https://www.fda.gov/media/155038/download FDA. (2017) Emergency Use Authorization of Medical Products and Related Authorities, Guidance for Industry and Other stakeholders FDA. At-Home OTC COVID-19 Diagnostic Tests. Retrieved Jun 12, 2023, from https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list FDA. COVID-19 Emergency Use Authorizations for Medical Devices. https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices FDA. FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19. Retrieved July 15, 2023, from https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic FDA. In Vitro Diagnostics Emergency Use Authorizations (EUAs) - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2. Retrieved Jun 12, 2023, from https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-emergency-use-authorizations-euas-serology-and-other-adaptive-immune-response FDA. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2. Retrieved Jun 12, 2023, from https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 GIBBS , J. & JAVITT , G. (2021) A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics. Food and Drug Law Journal. 76, 398-440. H.U. Group. Types and characteristics of the COVID-19 tests Retrieved Sep 5, 2023 from https://www.hugp.com/en/covid-19/general/index.html Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events. (2010). Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary. National Academies Press (US). MedTech Europe. Is the IVD Regulation Framework ready for Class D Devices? Retrieved Sep 8, 2023 from https://www.medtecheurope.org/wp-content/uploads/2020/10/medtech-europe-reflection-paper-class-d-infrastructure-under-ivdr-transition-october-2020-1.pdf MHRA. (2020) Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak. https://www.gov.uk/guidance/exceptional-good-distribution-practice-gdp-flexibilities-for-medicines-during-the-coronavirus-covid-19-outbreak#facilities-and-equipment Moshkovits, I., & Shepshelovich, D. (2022). Emergency Use Authorizations of COVID-19-Related Medical Products. JAMA internal medicine, 182(2), 228–229. Peeling, R. W., Heymann, D. L., Teo, Y. Y., & Garcia, P. J. (2022). Diagnostics for COVID-19: moving from pandemic response to control. Lancet (London, England), 399(10326), 757–768. Pérez-López, B., & Mir, M. (2021). Commercialized diagnostic technologies to combat SARS-CoV2: Advantages and disadvantages. Talanta. 225, 121898. PIC/S (2014) PIC/S Guide to good distribution practice for medicinal products. Retrieved Aug. 25,2023 from https://picscheme.org/docview/3450 Reuter, E. (March 27, 2023) FDA details plan to end emergency use authorizations. Retrieved Aug. 26, 2023 from https://www.medtechdive.com/news/fda-device-pandemic-transition-guidance-final/645972/ Shuren, J., & Stenzel, T. (2020). Covid-19 Molecular Diagnostic Testing - Lessons Learned. The New England journal of medicine, 383(17), e97. https://doi.org/10.1056/NEJMp2023830 US FDA. Policy for Coronavirus Disease-2019 Tests (Revised). https://www.fda.gov/media/135659/download US FDA. Summary of Process for EUA Issuance. Retrieved Mar 7, 2023, from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/summary-process-eua-issuance What are the regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"? (2017.02.03) The European GDP Association. Retrieved Aug. 25,2023 from https://www.good-distribution-practice-group.org/good-distribution-practice-news_05829_What-are-the-regulatory-Definitions-for--22Ambient-22---22Room-Temperature-22-and--22Cold-Chain-22.html WHO Coronavirus (COVID-19) Dashboard. Retrieved Sep 4, 2023 from https://covid19.who.int/?mapFilter=deaths WHO. (2019, Aug 6) In vitro diagnostics: Frequently asked questions. Retrieved Aug. 25, 2023 from https://www.who.int/news-room/questions-and-answers/item/pqt-ivd-questions-and-answers WHO. (2022) WHO Emergency Use Listing Procedure version 9. Retrieved Aug 30, 2023 from https://cdn.who.int/media/docs/default-source/medicines/eulprocedure.pdf?sfvrsn=55fe3ab8_8&download=true WHO. Emergency use listing. Retrieved Aug. 25, 2023 from https://www.who.int/teams/regulation-prequalification/eul 代辦疾管署公費支付COVID-19檢驗費用申報及核付作業. https://www.nhi.gov.tw/Content_List.aspx?n=8989E115E6B3455F&topn=5FE8C9FEAE863B46 李爾芳 (2021) 全球體外診斷醫療器材產業因新冠亦請影響概況. ITIS產業評析 李曜珊 (2020) 新型冠狀病毒檢驗試劑之國內外法規管理況及上市要求. 當代醫藥法規月刊 119: 1-16. 周晨蕙, 施雅薰 (2021) COVID-19疫情下我國藥事法專案核准制度議題-以國際藥物緊急核准上市機制為借鏡. 科技法律透析 第33卷第10期49-72 食品藥物管理署(2020)檢驗試劑專案製造法規及申請流程. Retrieved Oct. 24, 2023 from http://covid19platform.nhri.edu.tw/download/01.pdf 食品藥物管理署(2021) 出席2021年第20屆國際醫療器材法規管理論壇之視訊會議報告. Retrieved Oct. 21, 2023 from https://report.nat.gov.tw/ReportFront/PageSystem/reportFileDownload/C11000228/001 食品藥物管理署(2022) 111年度第1次醫療器材法規及管理溝通討論會議. Retrieved Apr. 14, 2023 from https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637842276526503538&type=1 食品藥物管理署(2022)。食藥署強化家用抗原新型冠狀病毒檢驗試劑上市前審查、邊境管理及上市後把關,讓國人安心防疫。Retrieved Sep. 26, 2023 from https://www.fda.gov.tw/TC/newsContent.aspx?cid=4&id=t601077. 食品藥物管理署(2023) 因應嚴重特殊傳染性肺炎(COVID-19)申請醫療器材專案輸入之核准名單(110.07.09) Retrieved Jun. 14, 2023 from https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f638163863194586916&type=3&iid=11672 食品藥物管理署(2023) . 因應嚴重特殊傳染性肺炎(COVID-19)申請醫療器材專案輸入之核准名單(112.05.01) Retrieved Jun 12, 2023, from https://www.fda.gov.tw/tc/site.aspx?sid=11669&r=1411817999 陳婕翎(Aug 4, 2020) 為何檢測新冠病毒要看Ct值高低?病毒專家這麼說. 聯合報. Retrieved Sep 5, 2023 from https://rcevi.cgu.edu.tw/p/406-1030-77329,r520.php?Lang=zh-tw 陳葦庭 (2021.03) 獨家直擊疫苗配送基地 裕利為何能3小時緊急應變? 商業週刊, 1739:30-31 黃阡阡 (2021.08.09). 挾冷鏈倉儲優勢 裕利獨擒新冠疫苗配送. 今週刊, 1285:60-61. 萬文隆(2004)。深度訪談在質性研究中的應用,生活科技教育月刊,37(4) 衛生福利部食品藥物管理署食藥戰情中心. (2021) 藥政動員業務介紹 醫療器材(QMS/QSD)製造許可暨廢止登錄資料集. https://www.fda.gov.tw/TC/siteContent.aspx?sid=2318 | - |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/91757 | - |
dc.description.abstract | 自2019年底爆發嚴重特殊傳染性肺炎(COVID-19)後,全球已造成逾695萬人死亡。該疾病的傳染性及致死率嚴重考驗著各國政府應變及資源取得及配置能力。為加速民眾快速取得預防及治療所需的藥物(含藥品及醫療器材),各國政府啟動了緊急使用授權(Emergency Use Authorization,EUA) 的措施,以加速新開發未經正常查驗登記程序上市的藥物能夠儘早供給到市面。體外診斷試劑(In vitro diagnosis test)為此次疫情大量適用EUA的醫療器材。體外診斷試劑可快速篩出受感染的病人,使相關單位可快速匡列出感染患者進行隔離避免疾病擴散。本論文以體外診斷試劑為例來了解國內外EUA法規,並利用深度訪談法分別訪問了醫療器材輸入業者、倉儲物流公司及醫院檢驗科,以了解EUA供應鏈在各環節所面臨到的問題並提出建議。探討之議題包含國內EUA法規的完整性、申請流程、輸入業者產品的供應、醫療器材的儲存及運送、醫療院所使用的情形、到上市後及疫情後的相對應措施等。產品取得EUA只是一個開端,後續是否有足夠的醫療量能(人力及物力)來維持該項醫療服務亦是需要關注的焦點。 | zh_TW |
dc.description.abstract | Since the outbreak of COVID-19 at the end of 2019, it has resulted in over 6.95 million deaths. The infectiousness and fatality rate of the disease have posed challenges to the ability to respond, to acquire and allocate resources of governments worldwide. To expedite the public's access to the pharmaceutical drugs and medical devices that are needed for prevention and treatment of the disease, governments around the world have initiated Emergency Use Authorization (EUA) or similar measures. These measures aim to accelerate the availability of newly developed drugs and medical devices on the market without undergoing the normal inspection and registration procedures.
Among the medical devices, in vitro diagnostic (IVD) tests are widely applicable for the use of EUA during this pandemic. These tests can rapidly identify infected individuals, enabling health authorities to quickly identify and quarantine infected patients to prevent the spread of the disease. This paper takes in vitro diagnostic tests as an example to understand the EUA regulations in Taiwan, the U.S., European Committee and WHO. It utilizes in-depth interviews with medical device importers, warehouse logistics provider, and hospital testing laboratory to understand the challenges faced in the EUA supply chain at various stages and provide suggestions for improvements. Topics discussed include the comprehensiveness of Taiwan EUA regulations, the application process, the supply of products by importers, storage and transportation of medical device, usage in healthcare institutions, and subsequent measures in post-market and after the pandemic. Obtaining EUA for a product is just the beginning, whether there are sufficient medical capabilities (both personnel and resources) to sustain the healthcare service should be also taken into consideration when we discuss EUA as a whole. | en |
dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2024-02-22T16:35:06Z No. of bitstreams: 0 | en |
dc.description.provenance | Made available in DSpace on 2024-02-22T16:35:06Z (GMT). No. of bitstreams: 0 | en |
dc.description.tableofcontents | 口試委員審定書 i
誌 謝 ii 中文摘要 iii 英文摘要 iv 口試委員審定書 vi 圖 次 ix 表 次 x 第一章 緒論 1 1.1 研究背景 1 1.2 研究動機 2 1.3 研究架構及方法 4 第二章 各國緊急使用授權的管理 5 2.1 COVID-19 試劑的種類 5 2.2 WHO- Emergency Use Listing (EUL) 8 2.3.1. 法源依據 8 2.3.2. 審查流程 8 2.3.3. 審查困境 11 2.3 美國- Emergency Use Authorization (EUA) 12 2.3.1. 法源依據 12 2.3.2. 審查流程 12 2.3.3. 審查困境 18 2.4 歐盟 Conditional Marketing Authorization (CMA) 20 2.4.1. 法源依據 20 2.4.2. 審查流程 20 2.4.3. 審查困境 22 2.5 台灣- 專案核准 24 2.5.1. 法源依據 24 2.5.2. 審查流程 24 2.5.3. 審查困境 27 2.6 小結 28 第三章 我國緊急使用授權制度之實務運作與檢討 31 3.1 研究目的 31 3.2 研究方法 32 3.3 醫療器材輸入業者 34 3.3.2. 申請費用及數量 34 3.3.3. EUA申請及供貨 36 3.3.4. 上市後的要求 39 3.3.5. 後疫情的正式查驗登記 41 3.4 醫藥物流業者 43 3.4.1. GMP及GDP相關規定 43 3.4.2. 國內業者量能 45 3.5 終端使用者-醫療院所 50 3.5.1. 價格 50 3.5.2. 採購 51 3.5.3. 醫院量能 51 第四章 研究發現與建議 54 4.1 研究發現 54 4.2 研究建議 56 第五章 結論 67 參考文獻 68 附錄 73 附錄 1. 訪談問題- 輸入業者的法規人員 73 附錄 2. 訪談問題- 輸入業者的業務單位 77 附錄 3. 訪談問題- 倉儲運輸業者 80 附錄 4. 訪談問題- 醫院檢驗科 85 | - |
dc.language.iso | zh_TW | - |
dc.title | 從業者及醫療院所觀點檢視台灣醫療器材緊急使用授權的法制規範與實務挑戰 - 以 COVID-19檢驗試劑為例 | zh_TW |
dc.title | Analysis of Taiwan’s Medical Device EUA regulations and challenges from industry and hospital’s perspectives- A case study of COVID-19 diagnostic tests | en |
dc.type | Thesis | - |
dc.date.schoolyear | 112-1 | - |
dc.description.degree | 碩士 | - |
dc.contributor.oralexamcommittee | 吳全峰;張濱璿 | zh_TW |
dc.contributor.oralexamcommittee | Chuan-Feng Wu;Pin-Hsuan Chang | en |
dc.subject.keyword | COVID-19,緊急使用授權,醫療器材,體外診斷試劑, | zh_TW |
dc.subject.keyword | COVID-19,Emergency Use Authorization,EUA,In vitro diagnostic tests, | en |
dc.relation.page | 88 | - |
dc.identifier.doi | 10.6342/NTU202400245 | - |
dc.rights.note | 同意授權(全球公開) | - |
dc.date.accepted | 2024-02-02 | - |
dc.contributor.author-college | 進修推廣學院 | - |
dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | - |
顯示於系所單位: | 生物科技管理碩士在職學位學程 |
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