產業監測
各國政府因應COVID-19之措施與機制
2021-01-10

美國

▪ Emergency Use Authorization, EUA : 緊急使用授權: 醫療設備、檢測、藥物 (2020.02.04)

▪ Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (2020.02.29)

▪ Coronavirus Treatment Acceleration Program (CTAP);治療藥物審查加速方案 (2020.03.31)

▪ 57 Guidance Documents (e.g. Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency)

美國已核准118項檢測試劑、37 LDTs、3藥物、其他40項(PPE.呼吸機.面罩…等) (6/26資料)

※ 台灣企業:德必碁、瑞磁、博錸取得 EUA-authorized;金萬林 (合作夥伴PacGenomics)、泉沂、聯亞生技 EUA-notified。


大陸

▪ 医疗器械应急审批 (2020.01)

▪ 2019新型冠状病毒核酸检测试剂注册技术审评要点(2020.02)

▪ 2019新型冠状病毒抗原抗体检测试剂注册技术审评要点(2020.02)

大陸已批准42個檢測試劑(21項核酸、 21項抗體)、1核酸分析軟體 (6/29資料)


歐盟

▪ Guidance for medicine developers and companies on COVID-19 (2020.03)

▪ Guidance on Apps supporting the fight against COVID 19 pandemic in relation to data protection (2020/4)

▪ EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines (2020.5.4)

  • EMA plan for emerging health threats
  • Rapid scientific advice
  • Rapid agreement of a paediatric investigation plan and rapid compliance check
  • Rolling review
  • Marketing authorisation
  • Extension of indication and extension of marketing authorisation
  • Compassionate Use

歐盟已有311項試劑取得CE-IVD (134項核酸177項抗體) (5/6資料)


韓國

▪ Emergency Use Approval and Listing (EUAL) (2020.02.04)

▪ Guidelines on Regulatory Review and Approval of COVID-19 IVD products(2020.04)

▪ Korea New Deal-完善10大產業法規:針對大數據/AI、醫療技術、醫療保健、電子商務…等修正65條法規;鬆綁遠距醫療、遠程教育線上業務與其他無接觸式運型產業(2020.4)

韓國共5項試劑獲核准使用,32項試劑核准出口 (4/29資料)


澳洲

▪ Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (2020.03)

▪ Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 (2020.03)

▪ Expedited COVID-19 medical device application process(2020.03)

▪ COVID-19 point-of-care tests(2020.04)

澳洲共核准48項試劑 (17項為核酸、 31項為抗體) (5/6資料)

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