국내 허가 및 긴급사용승인된 코로나19 바이러스감염증 치료제의 허가사항 비교 고찰

• 영문명: Comparison of Product Information for COVID-19 Treatments Marketing Authorized or Emergency Use Approved in Korea
• 발행기관: 대한약학회
• 저자명: 최민정 서현옥 도희정 김영림 최경숙 박윤주 서경원 정지원 김지연 박인숙 이원재 기성환
• 간행물 정보: 『약학회지』제67권 제3호(2023년), 145~157쪽, 전체 13쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2023.06.30

영문 초록

In a situation where the development of various treatments is urgently needed to overcome the global outbreak of coronavirus disease 2019 (COVID-19) and the sequential emergence of new variant viruses, Ministry of Food and Drug Safety (MFDS) made tremendous efforts to promptly supply the safe and effective therapeutics manufactured by local and global companies through accelerated marketing authorization or emergency use approvals. To date, seven products (including overlapped) have received marketing authorization or emergency use approvals from MFDS, and their indicated patient group according to the severity, efficacy, and safety information are different by each products. Therefore, this study is to compare the product information and the major clinical outcomes obtained from clinical studies of COVID-19 treatments authorized or approved for emergency use in Korea and to introduce the MFDS’s efforts for establishment of accelerated approval system for COVID-19 treatment and development of relevant guidelines. It is hoped that this study will serve as a reference for the latecomers who is preparing the development of therapeutics for emerging infectious diseases in the future.

목차

서 론(Introduction)

본 론(Main body)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Ministry of Food and Drug Safety Covid-19 therapeutics Marketing authorization Emergency use approval