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KMID : 0370220230670030145
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Yakhak Hoeji
2023 Volume.67 No. 3 p.145 ~ p.157
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Comparison of Product Information for COVID-19 Treatments Marketing Authorized or Emergency Use Approved in Korea
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Choi Min-Joung
Seo Hyun-Ok
Doh Hea-Jeong
Kim Young-Lim
Choi Kyoung-Suk
Park Youn-Joo
Seo Kyung-Won
Joung Jee-Won
Kim Ji-Yeon
Park In-Suk
Lee Won-Jae
Ki Sung-Hwan
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Abstract
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In a situation where the development of various treatments is urgently needed to overcome the global outbreakof coronavirus disease 2019 (COVID-19) and the sequential emergence of new variant viruses, Ministry of Food and DrugSafety (MFDS) made tremendous efforts to promptly supply the safe and effective therapeutics manufactured by local andglobal 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 indicatedpatient group according to the severity, efficacy, and safety information are different by each products. Therefore, this studyis to compare the product information and the major clinical outcomes obtained from clinical studies of COVID-19treatments authorized or approved for emergency use in Korea and to introduce the MFDS’s efforts for establishment ofaccelerated approval system for COVID-19 treatment and development of relevant guidelines. It is hoped that this studywill serve as a reference for the latecomers who is preparing the development of therapeutics for emerging infectiousdiseases in the future.
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KEYWORD
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Ministry of Food and Drug Safety, Covid-19 therapeutics, Marketing authorization, Emergency use approval
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FullTexts / Linksout information
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Listed journal information
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