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- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
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- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
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ICMC (International Certification Management Center Co., Ltd.)
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체외진단인허가현황. [공유] 국내 코로나19 검사키트 품목허가 76개
- Admin Hits:491
- 2022-02-06 10:53:00
코로나가 일상화된지 2년이 되었네요, '위드코로나'로 지내게 되면서, 대부분 한번쯤은 코로나 검사를 받아보셨을 겁니다.
그렇다면 국내 코로나 19 검사키트의 품목 허가 현황은 어떻게 될까요?
ICMC (주)해외인증경영센터는 20년 이상의 노하우로 체외진단의료기기에 관한 전주기적(품목 및 제조 인허가, 임상적 성능시험, 사후관리) 기술자문 서비스를 제공합니다. 홈페이지 상담센터>인허가문의를 이용해 주세요.
식약처의 허가 및 IND 승인(검사키트 제외) 정보에 따르면, 현재 긴급사용승인된 적응증을 가진 품목을 포함해 코로나19 치료제 3개 품목, 백신 5개 품목, 검사키트 76개 품목이 허가됐다. 또한 IND 승인돼 진행 중이거나 종료된 품목은 치료제 28개 품목, 백신 11개 품목이다.
출처 : 히트뉴스(http://www.hitnews.co.kr)
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