감염병 체외진단용 의료기기 현황과 전망 - 제품 개발 및 임상적 성능시험 설문조사
Current Status and Perspectives for in vitro Medical Devices for Infectious Disease Diagnosis - Survey of Product Development and Clinical Trials
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배경: 코로나19 팬데믹 이후 체외진단의료기기의 성장은 괄목할 만하다. 체외진단의료기기의 개발과 임상적 성능시험, 국내 및 해외 인허가 등 다양한 과정에서의 애로사항과 앞으로 개선 및 지원을 주력해야 하는 부분이 무엇인지 우리나라 체외진단의료기기 기업을 대상으로 설문조사를 시행하였다. 방법: 한국체외진단의료기기협회에 등록된 기업을 대상으로 구글 설문지를 이용하여 2021년 11월부터 12월까지 설문조사를 실시하였다. 질문은 체외진단의료기기의 개발 대상 감염병의 종류와 임상적 성능평가의 목적, 임상시험에 대한 애로사항과 지원이 필요한 부분이 무엇인지에 대한 질문을 포함하여 리커트 척도 혹은 백분율로 알아보았다. 44개 기업 중 23개(52.3%)가 회신을 하였다. 결과: 체외진단의료기기 기업은 임상적 성능시험 시 임상시험기관과의 매칭이 가장 어렵고, 국내 인허가 시 식품의약품안전처의 심사 및 허가가 지연되는 점이 큰 난관이라고 응답했다. 현재 가장 활발하게 개발하는 체외진단의료기기는 신종 코로나바이러스(42.7%)에 이어 인플루엔자(23.5%) 순이었다. 임상적 성능시험의 목적으로는 식품의약품안전처 승인(91.3%)에 이어 유럽 승인(60.9%)이 뒤를 이었다. 결론: 감염병 개발 체외진단의료기기 기업의 설문조사를 통해 경쟁력과 수출을늘리기 위해서는 임상 검체를 충분히 보유한 우수한 임상시험기관의 매칭, 정확한 임상 성능 평가 및 식품의약품안전처의 빠른 심사 및 허가 과정이 필요함을 알 수 있었다.
Abstract
Background: The in vitro diagnostic (IVD) medical device industry has experienced remarkable growth during the COVID-19 pandemic. We here survey the existing difficulties in addressing various processes, including IVD development, clinical trials, domestic and overseas licensing, and areas in which improvement efforts and support should be focused. Methods: A survey of companies registered in the Korea in vitro Diagnostic Association between November and December 2021was conducted using a Google questionnaire. In addition to basic questions about IVD development for infectious diseases and clinical trials, participants were asked for feedback regarding targeted infectious agents and hurdles faced in clinical trials. Twenty-three (52.3%) of 44 companies responded to our survey. For scoring, we either used the Likert scale or calculated the percentage of multiple answers. Results: Matching with a clinical trial agency was the most difficult aspect of clinical trials, and delays in review and approval by the Korean Ministry of Food and Drug Safety (KMFDS) was a major challenge facing domestic licensing. Currently, the most actively targeted IVD development arena is COVID-19 (42.7%) followed by influenza (23.5%). The major purpose of clinical trials is to obtain KMFDS approval (91.3%), followed by European IVDR (in vitro Diagnostic Regulation) approval (60.9%). Conclusions: The survey revealed that matching with well-prepared clinical trial institutions with sufficient stored clinical samples, accurate clinical performance analysis, and a rapid KMFDS review and approval process are necessary to enhance competitiveness and export.
참고문헌 (15)
- "Food & Drug statistical yearbook 2021. GPRN 11-1471000-000165-10" (2021)[URL]
- "Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices" (2021)[URL]
- "First trade surplus for medical devices, continuous reinforcement of innovative regulatory services" (2021)[URL]
- "Industry analysis and policy research of medical device for diagnosis. KHIDI-CHIP-R-2020-1" (2021)[URL]
- "Medical device industry analysis report 2020" (2021)[URL]
- "2020 Medical device approval report. GPRN 11-1471000-000216-10" (2021)[URL]
- Ravi N, "Diagnostics for SARS-CoV-2 detection : A comprehensive review of the FDA-EUA COVID-19 testing landscape", Biosens Bioelectron, 165, pp.112454~ (2020)
- Dinnes J, "Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection", Cochrane Database of Syst Rev, 3, pp.CD013705~ (2021)
- Wang YC, "Current diagnostic tools for coronaviruses-From laboratory diagnosis to POC diagnosis for COVID-19", Bioeng Transl Med, 5, pp.e10177~ (2020)
- "Test directory" (2022)[URL]
- "Act on In Vitro Diagnostic Medical Devices. Act no. 16433, Apr. 30, 2019"[URL]
- Ministry of Health and Welfare, "Infectious Disease Surveillance Yearbook, 2019" (2020), Korea Disease Control and Prevention Agency
- Lee H, "Impact of public health interventions on seasonal influenza activity during the COVID-19 outbreak in Korea", Clin Infect Dis, 73, pp.e132~e140 (2021)
- "Bioethics And Safety Act. Act No. 16372, Apr. 23, 2019"[URL]
- National Institute of Medical Device Safety Information, "National Certified Medical Device Regulatory Affairs Specialist 1 — Premarket Approval" (2021), Chaoreum